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Intervenciones educativas, de apoyo y conductuales para mejorar el uso de aparatos de presión positiva continua de las vías respiratorias en adultos con apnea obstructiva del sueño

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Referencias

Aloia 2001 {published data only}

Aloia MS, Di Dio L, Ilnicky N, Perlis ML, Greenblatt DW, Giles DE. Improving compliance with nasal CPAP in older adults with OAHS. Sleep & Breathing 2001;5(1):13‐21.
Aloia MS, Ilnicky N, Di Dio P, Perlis M, Greenblatt DW, Giles DE. Neuropsychological changes and treatment compliance in older adults. Journal of Psychosomatic Research 2003;54(1):71‐6.

Aloia 2012a {unpublished data only}

Aloia MS, Arnedt JT, Strand M, Millman RP, Borrelli B. Motivational Enhancement to Improve Adherence to Positive Airway Pressure in Patients with Obstructive Sleep Apnea: A Randomized Controlled Trial. www.journalsleep.org. Accepted for publication 6 May 2013.

Aloia 2012b {unpublished data only}

Aloia MS, Arnedt JT, Strand M, Millman RP, Borrelli B. Motivational Enhancement to Improve Adherence to Positive Airway Pressure in Patients with Obstructive Sleep Apnea: A Randomized Controlled Trial. www.journalsleep.org. Accepted for publication 6 May 2013.

Basoglu 2011 {published and unpublished data}

Basoglu OK, Midilli M, Midilli R, Bilgen C. Adherence to continuous positive airway pressure therapy in obstructive sleep apnea syndrome: effect of visual education. Sleep & Breathing 2012;16(4):1193‐200.

Chervin 1997 {published data only}

Chervin RD, Theut S, Bassetti C, Aldrich MS. Compliance with nasal CPAP can be improved by simple interventions. Sleep 1997;20(4):284‐9.

DeMolles 2004 {published data only}

DeMolles DA, Sparrow D, Gottlieb DJ, Friedman R. A pilot trial of a telecommunications system in sleep apnea management. Medical Care 2004;42(8):764‐9.

Epstein 2000 {unpublished data only}

Epstein L, Graham L Turner A, Larkin E, Garshick E, Ayas N, et al. Comparison of two methods for achieving CPAP compliance. American Journal of Respiratory and Critical Care Medicine 2000;161(3 Suppl):A358.

Fox 2012 {published data only}

Fox N, Hirsch‐Allen AJ, Goodfellow E, Wenner J, Fleetham JA, Ryan CF, et al. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep 2012;35(4):477‐81.

Hoy 1999 {published data only}

Hoy CJ, Vennelle M, Kingshott RN, Engleman HM, Douglas NJ. Can intensive support improve continuous positive airway pressure use in patients with the sleep apnea/hypopnea syndrome?. American Journal of Respiratory Ciritical Care Medicine 1999;159(4):1096‐100.

Hui 2000 {published data only}

Hui DSC, Chan JKW, Choy DKL, Ko FWS, Li TST, Leung RCC, et al. Effects of augmented continuous positive airway pressure education and support on compliance and outcome in a Chinese population. Chest 2000;117(5):1410‐15.

Lewis 2006 {published data only}

Lewis KE, Bartle IE, Watkins AJ, Seale L, Ebden P. Simple interventions improve re‐attendance when treating the sleep apnoea syndrome. Sleep Medicine 2006;7(3):241‐7.

Meurice 2007a {published data only}

Meurice J‐C, Ingrand P, Portier F, Arnulf I, Rakotonanahari D, Fournier E, et al. A multicentre trial of education strategies at CPAP induction in the treatment of severe sleep apnoea‐hypopnoea syndrome. Sleep Medicine 2007;8(1):37‐42.

Meurice 2007b {published data only}

Meurice J‐C, Ingrand P, Portier F, Arnulf I, Rakotonanahari D, Fournier E, et al. A multicentre trial of education strategies at CPAP induction in the treatment of severe sleep apnoea‐hypopnoea syndrome. Sleep Medicine 2007;8(1):37‐42.

Meurice 2007c {published data only}

Meurice J‐C, Ingrand P, Portier F, Arnulf I, Rakotonanahari D, Fournier E, et al. A multicentre trial of education strategies at CPAP induction in the treatment of severe sleep apnoea‐hypopnoea syndrome. Sleep Medicine 2007;8(1):37‐42.

Meurice 2007d {published data only}

Meurice J‐C, Ingrand P, Portier F, Arnulf I, Rakotonanahari D, Fournier E, et al. A multicentre trial of education strategies at CPAP induction in the treatment of severe sleep apnoea‐hypopnoea syndrome. Sleep Medicine 2007;8(1):37‐42.

Olsen 2012 {published data only}

Olsen S, Smith S, Oei T, Douglas J. Motivational Interviewing (MINT) improves continuous positive airway pressure (CPAP) acceptance and adherence: a randomised controlled trial. Journal of Consulting and Clinical Psychology 2012;80(1):151‐63.

Parthasarathy 2012 {published and unpublished data}

Parthasarathy S, Wendel C, Haynes PL, Atwood C, Kuna ST. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. Journal of Clinical Sleep Medicine 2013 Jun 15;9(6):543‐50.

Richards 2007 {published data only}

Richards D, Bartlett DJ, Wong K, Malouff J. Increased adherence to CPAP with a group cognitive behavioral treatment intervention: a randomized trial. Sleep 2007;30(5):635‐40.

Roecklein 2010 {published data only}

Roecklein KA, Schumacher JA, Gabriele JM, Fagan C, Baran AS, Richert AC. Personalized feedback to improve CPAP adherence in obstructive sleep apnea. Behavioral Sleep Medicine2010; Vol. 8, issue 2:105‐12.

Schiefelbein 2005 {published data only}

Schiefelbein J. Internet interventions for older persons with obstructive sleep apnea: preparedness and problem‐solving confidence [Dissertation]. University of Kansas2005.

Smith 2006 {published data only}

Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, et al. Telehealth services to improve non‐adherence: a placebo‐controlled study. Telemedicine Journal and E‐Health 2006;12(3):289‐96.

Smith 2009 {published data only}

Smith Carol E, Dauz E, Clements F, Werkowitch M, Whitman R. Patient education combined in a music and habit‐forming intervention for adherence to continuous positive airway (CPAP) prescribed for sleep apnea. Patient Education and Counseling2009; Vol. 74, issue 2:184‐90. [0738‐3991]

Sparrow 2010 {published data only}

Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax2010; Vol. 65, issue 12:1061‐6.

Stepnowsky 2007 {published data only}

Stepnowsky CJ, Palau JJ, Marler MR, Gifford AL. Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea. Journal of Medical Internet Research 2007;9(2):e14.
Stepnowsky CJ, Palau JJ, Zamora T, Marler M. Effect of wireless monitoring on CPAP adherence and treatment efficacy. Telemedicine and E‐Health 2008;14(Suppl 1):25.

Taylor 2006 {unpublished data only}

Taylor Y, Eliasson A, Andrada T, Kristo D, Howard R. The role of telemedicine in CPAP compliance for patients with obstructive sleep apnea syndrome. Sleep & Breathing 2006;10(3):132‐8.
Taylor YL. A comparison between a telemedicine and traditional management model of care with nasal continuous positive airway pressure use among individuals with obstructive sleep apnea syndrome [Dissertation]. George Washington University2003.
Taylor YL, Eliasson A, Kristo D, Andrala T, Bigott T, Ephraim P, et al. Can telemedicine improve compliance with nasal CPAP? [Abstract]. Sleep 2003;26:A263.

Wang 2011a {published data only}

Wang W, He G, Wang M, Liu L, Tang H. Effects of patient education and progressive muscle relaxation alone or combined on adherence to continuous positive airway pressure treatment in obstructive sleep apnea patients. Sleep & Breathing 2012;16(4):1049‐57.

Wang 2011b {published data only}

Wang W, He G, Wang M, Liu L, Tang H. Effects of patient education and progressive muscle relaxation alone or combined on adherence to continuous positive airway pressure treatment in obstructive sleep apnea patients. Sleep & Breathing 2012;16(4):1049‐57.

Wang 2011c {published data only}

Wang W, He G, Wang M, Liu L, Tang H. Effects of patient education and progressive muscle relaxation alone or combined on adherence to continuous positive airway pressure treatment in obstructive sleep apnea patients. Sleep & Breathing 2012;16(4):1049‐57.

Wang 2011d {published data only}

Wang W, He G, Wang M, Liu L, Tang H. Effects of patient education and progressive muscle relaxation alone or combined on adherence to continuous positive airway pressure treatment in obstructive sleep apnea patients. Sleep & Breathing 2012;16(4):1049‐57.

Wiese 2005 {published data only}

Wiese HJ, Boethel C, Phillips B, Peters J, Viggiano T. CPAP compliance: video education may help! Chest 2002; Nov 2‐7; San Diego. 2002; Vol. 122, issue 4 suppl:P256.
Wiese HJ, Boethel C, Phillips B, Wilson JF, Peters J, Viggiano T. CPAP compliance: Video education may help!. Sleep Medicine 2005;6(2):171‐4.

Damjanovic 2009 {published data only}

Damjanovic D, Fluck A, Bremer H, Muller‐Quernheim J, Idzko M, Sorichter S. Compliance in sleep apnoea therapy: influence of home care support and pressure mode. European Respiratory Journal 2009;33(4):804‐11.
Damjanovic D, Fluck A, Idzko M, Muller‐Quernheim J, Sorichter S. Nasal CPAP in the therapy of OSAS: Does a closer patient guidence and support increase compliance?. European Respiratory Journal 2005;26(Suppl 49):4521.

Fletcher 1991 {published data only}

Fletcher EC, Luckett RA. The effect of positive reinforcement on hourly compliance in nasal continuous positive airway pressure users with obstructive sleep apnea. American Review of Respiratory Disease 1991;134:936‐41.

Gupta 2011 {published data only}

Gupta S, Bollavaram N, Knapik S. At home patient directed daytime continuous positive airway pressure (CPAP) mask acclimatization prior to starting CPAP therapy. Chest 2011;140(4):824A. [DOI: 10.1378/chest.1117639]

Hirschowitz 2006 {published data only}

Hirshkowitz M, Gast H. Sleep‐related breathing disorders and sleepiness. Sleep Medicine Clinics 2006;1(4):491‐8.

Kajaste 2004 {published data only}

Kajaste S, Branderb PE, Telakivia T, Partinen M, Mustajokic P. A cognitive‐behavioral weight reduction program in the treatment of obstructive sleep apnea syndrome with or without initial nasal CPAP: a randomized study. Sleep Medicine 2004;5:125‐31.

Klein 2010 {published data only}

Klein C, Damjanovic D, Idzko M, Seuthe B, Walterspacher S, Kabitz H, et al. Compliance in sleep apnoea therapy: influence of home care support and pressure mode—a 5‐year follow‐up. Journal of Sleep Research 2010;19(Suppl 2):20.

Marshall 2003 {published data only}

Marshall MJ, Scammels C, Lowe S. Does proactive intervention influence compliance on continuous positive airway pressure therapy (CPAP)?. Respiratory Care 2003;48(11):1094.

Shaikh 2009 {published data only (unpublished sought but not used)}

Shaikh KR, Zaldivar G, Zarrouf F, Sirbu C, Cameron J, Linton J. Weekly phone calls vs brief patients education to improve CPAP compliance: a randomized controlled trial [abstract]. 23rd Annual Meeting of the Associated Professional Sleep Societies; 2009 6‐11 June; Seattle. 2009; Vol. 32, issue suppl:A215 [0658].

Signes‐Costa 2005 {published data only}

Signes‐Costa J, Chiner E, Andreu AL, Pastor E, Llombart M, Gomez‐Merino E, et al. Patient compliance with CPAP home based diagnosis and review preliminary report [Abstract]. European Respiratory Journal 2004;24(Suppl 48):567s.

Trupp 2011 {published data only}

Trupp RJ, Corwin EJ, Ahijevych KL, Nygren T. The impact of educational message framing on adherence to continuous positive airway pressure therapy. Behavioral Sleep Medicine 2011;9(1):38‐52.

Wenzel 2008 {published data only}

Wenzel M, Neifer C, Wenzel G, Kerl J, Jurgens K, Suchi S, et al. Follow‐up examination and probatory CPAP therapy of obstructive sleep apnoea increase the long‐term compliance [Poststationäre Nachsorge und probatorische CPAP‐Therapie schlafbezogener obstruktiver Atemstörungen steigern die Langzeitcompliance]. Pneumologie 2008;62(2):75‐9.

References to studies awaiting assessment

Bartlett 2010 {published and unpublished data}

Bartlett D, Moy E, Richards D, Wong K, Cistulli P, Espie C, et al. Assessing adherence to obstructive sleep apnoea treatment with two group educational interventions [Abstract]. Journal of Sleep Research 2010;19(Suppl 2):226.
Bartlett D, Moy E, Wong K, Richards D, Espie C, Cistulli P, Grunstein R. Can we increase adherence to CPAP treatment for obstructive sleep apnea (OSA) with a group cognitive behavioural therapy (CBT) treatment intervention: a randomised trial. Conference poster.
Bartlett D, Wong K, Richards D, Moy E, Espie C, Cistulli P, et al. A randomised controlled trial comparing enhanced behavioural intervention with standard education on CPAP adherence. 22nd Annual Scientific Meeting of the Australian Sleep Association and Australian Sleep Technologists Association: Sleep Down Under 2010 ‐ Biodiversity of Sleep; 2010 Oct 21‐23; Christchurch, New Zealand. 2010.

Fanfulla 2008 {published data only}

Fanfulla F, Taurino AE, Dal N, Piran M, Scalvini S, Fracchia C. CPAP use and weight control in obese OSA patient improves by a tele‐assistance program [Abstract]. European Respiratory Society 18th Annual Congress; 2008 Oct 3‐7; Berlin. 2008:[P790].

Peach 2003 {published data only}

Peach RF, Jelic S, Zhong X, Basner RC, Zimmerman BJ. Effect of self‐regulation and self‐monitoring on CPAP adherence in obstructive sleep apnea (OSA). Sleep 2003;26(Suppl):A263.

Aloia 2007

Aloia MS, Arnedt JT, Stanchina M, Millman RP. How early in treatment is PAP adherence established? Revisiting night‐to‐night variability. Behavioural Sleep Medicine 2007;5(3):229‐40.

Bandura 2004

Bandura A. Health promotion by social cognitive means. Health Education and Behavior 2004;31:143‐64.

Bollig 2010

Suzanne M Bollig. Encouraging CPAP adherence: it is everyone’s job. Respiratory Care 2010;55(9):1230–6.

Bravata 2011

Bravata DM, Concato J, Fried T, Ranjbar N, Sadarangani T, McClain V, et al. Continuous positive airway pressure: evaluation of a novel therapy for patients with acute ischemic stroke. Sleep 2011 Sep;34(9):1271‐7.

Dong 2013

Dong JY, Zhang YH, Qin LQ. Obstructive sleep apnea and cardiovascular risk: meta‐analysis of prospective cohort studies. Atherosclerosis 2013 Aug;229(2):489‐95.

Gay 2006

Gay P, Weaver T, Loube D, Iber C. Evaluation of positive airway pressure treatment for sleep related breathing disorders in adults. Sleep 2006;29(3):381‐401.

Giles 2006

Giles TL, Lasserson TJ, Smith BJ, White J, Wright J, Cates CJ. Continuous positive airways pressure for obstructive sleep apnoea. Cochrane Database of Systematic Reviews 2006, Issue 3. [DOI: 10.1002/14651858.CD001106.pub3]

Harsch 2004

Harsch IA, Schahin SP, Radespiel‐Troger M, Weintz O, Jahreib H, Fuchs FS, et al. CPAP treatment rapidly improves insulin sensitivity in patients with obstructive sleep apnea syndrome. American Journal of Respiratory & Critical Care Medicine 2004;169:156–62.

Higgins 2011

Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0. Cochrane Collaboration, 2011.

Kribbs 1993

Kribbs NB, Pack AI, Kline LR, Smith PL, Schwartz AR, Schubert NM, et al. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. American Review of Respiratory Disease 1993;147(4):887‐95.

Krieger 1992

Krieger J. Long‐term compliance with nasal continuous positive airway pressure (CPAP) in obstructive sleep apnea patients and non‐apneic snorers. Sleep 1992;15(6):S42‐6.

Lewis 2004

Lewis KE, Seale L, Bartle IE, Watkins AJ, Ebden P. Early predictors of CPAP use for the treatment of obstructive sleep apnoea. Sleep 2004;27(1):134‐8.

Lindberg 2006

Lindberg E, Berne C, Elmasry A, Hedner J, Janson C. CPAP treatment of a population‐based sample—what are the benefits and the treatment compliance?. Sleep Medicine 2006;7:553‐60.

Marin 2005

Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long‐term cardiovascular outcomes in men with obstructive sleep apnoea‐hypopnoea with or without treatment with continuous positive airway pressure: an observational study. The Lancet 2005;365(9464):1046‐53.

Martinez‐Garcia 2009

Martínez‐García MA, Soler‐Cataluña JJ, Ejarque‐Martínez L, Soriano Y, Román‐Sánchez P, Illa FB, et al. Continuous positive airway pressure treatment reduces mortality in patients with ischemic stroke and obstructive sleep apnea: a 5‐year follow‐up study. American Journal of Respiratory and Critical Care Medicine 2009;180:36‐41.

Martinez‐Garcia 2012

Martínez‐García MA, Campos‐Rodríguez F, Catalán‐Serra P, Soler‐Cataluña JJ, Almeida‐Gonzalez C, De la Cruz Morón I, et al. Cardiovascular mortality in obstructive sleep apnea in the elderly: role of long‐term continuous positive airway pressure treatment: a prospective observational study. American Journal of Respiratory and Critical Care Medicine 2012;186(9):909‐16.

Mooe 2001

Mooe T, Franklin KA, Holmstrom K, Rabben T, Wiklund U. Sleep‐disordered breathing and coronary artery disease: long‐term prognosis. American Journal of Respiratory and Critcal Care Medicine 2001;164(10):1910‐3.

Myhill 2012

Myhill PC, Davis WA, Peters KE, Chubb SA, Hillman D, Davis TM. Effect of continuous positive airway pressure therapy on cardiovascular risk factors in patients with type 2 diabetes and obstructive sleep apnea. Journal of Clinical Endocrinology and Metabolism 2012;97(11):4212‐8.

Olsen 2008

Olsen S, Smith S, Oei TP. Adherence to continuous positive airway pressure therapy in obstructive sleep apnoea sufferers: a theoretical approach to treatment adherence and intervention. Clinical Psychology Review 2008;28(8):1355‐71.

Parish 2003

Parish JM, Lyng PJ. Quality of life in bed partners of patients with obstructive sleep apnea or hypopnea after treatment with continuous positive airway pressure. Chest 2003;124(3):942‐7.

Pelletier 2001

Pelletier‐Fleury N, Rakotonanahary D, Fleury B. The age and other factors in the evaluation of compliance with nasal continuous positive airway pressure for obstructive sleep apnea syndrome. A Cox's proportional hazard analysis. Sleep Medicine 2001;2:225‐32.

Peppard 2000

Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep disordered breathing and hypertension. New England Journal of Medicine 2000;342:1378–84.

Pépin 1999

Pépin JL, Krieger J, Rodenstein D, Cornette A, Sforza E, Delguste P, et al. Effective compliance during the first 3 months of continuous positive airway pressure. Respiratory and Critical Care Medicine 1999;130(4):1124‐9.

Richard 2007

Richard W, Venker J, den Herder C, Kox D, van den Berg B, Laman M, et al. Acceptance and long‐term compliance of nCPAP in obstructive sleep apnea. European Archives of Oto‐Rhino‐Laryngology Sep 2007;264(9):1081‐6.

Sawyer 2011

Sawyer AM, Gooneratne N, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Medicine Reviews 2011 December;15(6):343–56.

SIGN 2003

Scottish Intercollegiate Guideline Network. Management of Obstructive Sleep Apnoea/Hypopnoea Syndrome in Adults. A National Clinical Guideline (June 2003). http://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&ved=0CDYQFjAA&url=http%3A%2F%2Fwww.sign.ac.uk%2Fpdf%2Fsign73.pdf&ei=qfAIUqDsDITfOO‐VgNgK&usg=AFQjCNGaohrd7TntSChxFxPEIp6UWnm1jQ&sig2=OFhtXVZ_dSi2cc5OPlW8cg&bvm=bv.50500085,d.ZWU (accessed 12 August 2013).

Sin 2002

Sin D, Mayers I, Man GC, Pawluck L. Long‐term compliance rates to continuous positive airways pressure in obstructive sleep apnoea. Chest 2002;121:430‐5.

Smith 2009a

Smith I, Lasserson TJ. Pressure modification for improving usage of continuous positive airway pressure machines in adults with obstructive sleep apnoea. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD003531]

Stepnowsky 2002

Stepnowsky CJ, Marler MR, Ancoli‐Israel S. Determinants of nasal CPAP compliance. Sleep Medicine 2002;3:239‐47.

Stepnowsky 2007a

Stepnowsky CJ, Palau JJ, Gifford AL, Ancoli‐Israel S. A self‐management approach to improving continuous positive airway pressure adherence and outcomes. Behavioural Sleep Medicine 2007;5(2):131‐46.

Sullivan 1981

Sullivan CE, Issa FG, Berthon‐Jones M. Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet 1981;1(8225):862–5.

Weaver 2003

Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, et al. Self‐efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep 2003;26(6):727‐32.

Weaver 2007

Weaver TE, Maislin G, Dinges DF, Bloxham T, George CFP, Greenberg H. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep 2007;30(6):711‐9.

Weaver 2010

Weaver TE, Sawyer AM. Adherence to continuous positive airway pressure treatment for obstructive sleep apnoea: Implications for future interventions. Indian Journal of Medical Research Feb 2010;131:245‐58.

Wells 2007

Wells RD, Freedland KE, Carney RM, Duntley SP, Stepanski EJ. Adherence, reports of benefits, and depression among patients treated with continuous positive airway pressure. Psychosomatic Medicine 2007;69(5):449–54.

Wild 2004

Wild MR, Engleman HM, Douglas NJ, Espie CA. Can psychological factors help us to determine adherence to CPAP? A prospective study. European Respiratory Journal 2004;24(3):461‐5.

Yaggi 2005

Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. New England Journal of Medicine 2005;353(19):2034‐41.

Zozula 2001

Zozula R, Rosen R. Compliance with continuous positive airway pressure therapy: assessing and improving treatment options. Current Opinion in Pulmonary Medicine 2001;7:391‐8.

References to other published versions of this review

Haniffa 2004

Haniffa M, Lasserson TJ, Smith I. Interventions to improve compliance with continuous positive airway pressure for obstructive sleep apnoea. Cochrane Database of Systematic Reviews 2004, Issue 4. [DOI: 10.1002/14651858.CD003531.pub2]

Smith 2009

Smith I, Nadig V, Lasserson TJ. Educational, supportive and behavioural interventions to improve usage of continuous positive airway pressure machines for adults with obstructive sleep apnoea. Cochrane Database of Systematic Reviews 2009, Issue 2. [DOI: 10.1002/14651858.CD007736]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Aloia 2001

Methods

Randomised parallel‐group trial. All randomly assigned participants accounted for

Participants

N = 12

Mean age: 65.5, AHI: 43.5, Desaturation: 77.05 ± 9.47

Inclusion criteria: > 55 years of age, RDI (AHI): > 10, Mini Mental Status Examination: > 25

Exclusion criteria: other ICSD, other treatment for apnoea, claustrophobia

Participants had received prior treatment with CPAP

Interventions

Intervention

Two sessions. Session 1: review of participants' sleep data; symptoms; review of performance of cognitive tests; review of importance of treatment; review of PSG and CPAP; discussion of advantages and disadvantages of treatment; development of goals for therapy. Session 2: examination of compliance data for week one; discussion of noticeable changes with treatment; discussion of changes not apparent (hypertension/cardiac problems); troubleshooting discomfort; discussion of realistic aims of treatment; review of treatment goals

Control

Two sessions: general discussion of sleep architecture and opinions on sleep clinic

Study duration: 12 weeks

Outcomes

  • Machine usage

  • Number of participants who were 'compliant' (> six hours per night of usage)

  • Vigilance testing

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation by 'urns', stratification by age, RDI, nadir O2 pretreatment, vigilance

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not done for treatment group assignment

'None of the subjects were told that their CPAP machines were measuring their compliance via internal microprocessors'

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Information not available

Aloia 2012a

Methods

Randomised parallel‐group study

Participants

N = 154

Intervention group: Age: 47.0, Male sex: 48%, AHI: 46.1, ESS: 12.6, BMI: 35

Control group: Age: 52, Male sex: 57%, AHI: 48.2, ESS: 11.9, BMI: 35.8

Inclusion criteria: new diagnosis of moderate to severe OSA by full in‐lab polysomnography, naive to CPAP

Exclusion criteria: diagnosis by split night polysomnography, severe neurological or unstable psychiatric illness, congestive heart failure, end‐stage renal disease

Interventions

Intervention

Two 45‐minute face‐to‐face education sessions delivered by a trained nurse one and two weeks after initiation of PAP treatment. One additional booster phone call at week three Education comprised pathophysiology, medical and behavioural consequences of OSA and benefits of treatment

Control

Standard care consisting of physician discussing the benefits of treatment before and after diagnosis. Regular follow‐up visits with physicians, usually eight to 10 weeks after PAP initiation

Study duration: 52 weeks

Outcomes

  • Machine usage (hours/night)

  • Withdrawals

  • Decisional balance

  • Self‐efficacy

Notes

The study comprised three treatment arms. We consider the effects of the two treatment arms and the one control arms as separate studies. Interventions were initiated one week after initiation of CPAP

Unpublished study. Currently under review for publication

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Participants were urn randomly assigned in a 1:1 ratio

Allocation concealment (selection bias)

Unclear risk

No sufficient information provided

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Participants, physicians and other healthcare providers were blinded to whether participants were enrolled in the study. Research staff who downloaded adherence data were blinded to group membership. Participants were informed that machine would be accessed periodically to determine 'how the device was working at night'. Given the nature of the intervention, it is unlikely that true blinding of participants was achieved. Furthermore, the same nurse delivered two different interventions in the study arms

Incomplete outcome data (attrition bias)
All outcomes

High risk

27 of 80 participants in intervention group and 25 of 74 participants in control group dropped out from the study. Non‐completers were not included in outcome analysis

Aloia 2012b

Methods

Randomised parallel‐group study

Participants

N = 147

Intervention group: Age: 52, Male sex: 45%, AHI: 45.7, ESS: 11.6, BMI: 35

Control group: Age: 52, Male sex: 57%, AHI: 48.2, ESS: 11.9, BMI: 35.8

Inclusion criteria: new diagnosis of moderate to severe OSA by full in‐lab polysomnography, naive to CPAP

Exclusion criteria: diagnosis by split night polysomnography, severe neurological or unstable psychiatric illness, congestive heart failure, end‐stage renal disease

Interventions

Intervention

Two 45‐minute face‐to‐face Motivational Enhancement Therapy (MET) sessions delivered by a trained nurse one and two weeks after initiation of PAP treatment. One additional booster phone call at week three. MET consisted of individually tailored counselling focused on addressing ambivalence regarding consistent use of PAP, participant‐specific information on OSA, symptom change, treatment expectations, goal development and refinement and enhancing participant's motivation

Control

Standard care involved the physician discussing the benefits of treatment before and after diagnosis. Regular follow‐up visits with physicians, usually eight to 10 weeks after PAP initiation

Study duration: 52 weeks

Outcomes

  • Machine usage (hours/night)

  • Withdrawals

  • Decisional balance

  • Self‐efficacy

Notes

The study comprised three treatment arms. We consider the effects of the two treatment arms and the one control arm as separate studies. Interventions were initiated one week after initiation of CPAP

Unpublished study. Currently under review for publication

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Participants were urn randomly assigned in a 1:1 ratio

Allocation concealment (selection bias)

Unclear risk

No sufficient information provided

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Participants, physicians and other healthcare providers were blinded to whether participants were enrolled in the study. Research staff who downloaded adherence data were blinded to group membership. Participants were informed that machine would be accessed periodically to determine 'how the device was working at night'. Given the nature of the intervention, it is unlikely that blinding of participants was achieved. Furthermore, the same nurse delivered two different interventions in the study arms

Incomplete outcome data (attrition bias)
All outcomes

High risk

26 of 73 participants in intervention group and 25 of 74 participants in control group dropped out from the study. Non‐completers were not included in outcome analysis

Basoglu 2011

Methods

Randomised, parallel‐group study

Participants

N = 133

Intervention group: Age: 53.7, Male sex: 82%, AHI 61, ESS: 10.3, BMI: 33.2

Control group: Age: 54, Male sex: 70%, AHI: 57.4, ESS: 12.4, BMI: 33

Inclusion criteria: newly diagnosed, moderate to severe OSA, CPAP naive

Exclusion criteria: use of sedatives, drug abuse, cardiac co‐morbidities, COPD, other sleep disorders

Interventions

Intervention

10‐Minute videotape on OSA, its consequences and CPAP therapy. In addition, routine information on diagnosis and treatment of OSA given by physician

Control

Standard information on OSA and CPAP therapy given by the same physician

Study duration: 24 weeks

Outcomes

  • N of adherent participants (CPAP use for at least four hours/night for at least 70% of nights)

  • CPAP usage per night

  • ESS

  • Factors predicting CPAP adherence

Notes

Unpublished information on study design and outcomes obtained from study authors

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation by a set of numbers prepared and randomly assigned by a clinician not involved in the study

Allocation concealment (selection bias)

Low risk

Randomisation by a third party

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The primary investigator and the statistician were blinded to the study group assignment. Participants were aware of machine usage monitoring. Given the nature of the intervention, it is unlikely that participant blinding was achieved

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All participants completed the study, and no data were missing

Chervin 1997

Methods

Randomised parallel‐group trial

Participants

N = 40

Mean age: 51.7, Mean AHI: 49.4, ESS: 10.9 ± 5.1, Lowest 02, Sat: 75.6% ± 14.4, MSLT: 6 ± 3.9

Recruited from clinic

Interventions

Intervention I

Telephone call each week during trial (max trial time of two months)

Intervention II

Two printed documents

Control

No additional support

Study duration: eight weeks

Outcomes

  • Machine usage

Notes

Two of 33 used Bi‐PAP. Both CPAP‐naive users and those who had been on CPAP before trial were studied. Reading done at enrolment and at between 1 to 2 months after enrolment

Difference in AHI between active and control groups at baseline

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random numbers table

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not done for treatment group assignment

Participants' readout of CPAP machine usage data during telephone call to clinic

Incomplete outcome data (attrition bias)
All outcomes

High risk

Non‐completers excluded from analysis

DeMolles 2004

Methods

Randomised parallel‐group study. Methods of randomisation not reported

Participants

N = 30

Mean age: 46, BMI: 38, AHI: 40, Functional Outcomes of Sleep Questionnaire: TLC: 15.3, Control: 13.8

Inclusion criteria: participants starting nasal CPAP therapy; > 18 years; English‐speaking; > 15 episodes of apnoea or hypopnoea/h

Exclusion criteria: not described

Interventions

Telephone‐linked communications technology (TLC) versus usual care. TLC consisted of a computerised digitised human speech programme. TLC asks questions designed to elicit information from participant regarding adherence, education and reinforcement

Study duration: eight weeks

Outcomes

  • Machine usage

  • Sleep symptoms

  • Functional outcomes of sleep questionnaire

  • Number of calls per participant

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Described as randomised; other information not available

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Participants aware of treatment group assignment

Intervention involved communication regarding participant's CPAP machine usage

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All completed

Epstein 2000

Methods

Randomised, parallel‐group study

Participants

N = 50

No baseline characteristics were reported. Participants recruited after diagnosis of OSA confirmed with polysomnography and before initiation with CPAP treatment. No information on withdrawals were reported

Inclusion criteria: not specified

Interventions

Education course aim at desensitisation versus standard physician follow‐up

Study duration: 24 weeks

Outcomes

  • Machine usage

Notes

Unpublished abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Described as randomised; information not available

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

No blinding undertaken

Not enough information available to ascertain awareness of CPAP machine usage

Incomplete outcome data (attrition bias)
All outcomes

High risk

Non‐completers excluded

Fox 2012

Methods

Randomised parallel‐group study

Participants

N = 75

Mean age: 53.5, Mean AHI: 41.6, ESS: Control group: 9.7, Intervention group: 9.9

Inclusion criteria: adult (≥ 19 years), moderate to severe OSA (AHI ≥ 15)

Exclusion criteria: active cardiopulmonary or psychiatric disease, previously treated for OSA, no access to telephone line in bedroom, not able to return for follow‐up

Interventions

Intervention

Physiological data (PAP adherence, applied PAP, mask leak, residual respiratory events) were downloaded using modem attached to the PAP device and sent across the telephone line each morning. Downloaded information was reviewed every weekday except holidays by the research coordinator, who contacted the participant if poor compliance or other problems with treatment (e.g. mask leak) were detected. Participants were advised over the phone or visited the PAP coordinator. Standard care identical to control group

Control

20‐Minute orientation to PAP session and mask fitting. Participants contacted after two days to check adherence and to troubleshoot problems, followed up at four to six weeks and at three months; each time, physiological data downloaded from machines and any problems with treatment addressed. In addition, data downloaded at eight weeks

Study duration: 12 weeks

Outcomes

  • Machine usage (minutes per day)

  • Adherence on nights PAP used

  • % days PAP used

  • Decrease in ESS

  • AHI on treatment

  • Length of time spent with participants

  • Overall sleep quality and side effects measured by visual analogue scales

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'...sequential numbered envelopes'

Allocation concealment (selection bias)

Unclear risk

envelopes were prepared by one of the study investigators

Blinding (performance bias and detection bias)
All outcomes

High risk

No blinding undertaken

Intervention involved communication regarding participant's CPAP machine usage

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

'intention to treat approach', high discontinuation rate (control group: 10/36, telemedicine group: 11/39)

Hoy 1999

Methods

Randomised, parallel study. Method of randomisation not reported. ITT

Participants

N = 80

78:2 (M:F), Mean age: 51, Mean AHI: 58, ESS: 13

Inclusion criteria: AHI ≥ 15, plus daytime sleepiness or two other major symptoms of the syndrome; resident within 50 miles of Edinburgh

Exclusion criteria: prior use of CPAP; coexisting COPD, asthma or neurological problems

Interventions

Intervention

Full explanation of need for and benefits of CPAP by sleep physician, 20‐minute video education programme, given mask to try for 20 minutes, titration of CPAP pressure overnight with following day discharge, nurses telephoned on days two and 21, reviewed in hospital at one, three and six months. Initial education at home with partner, two extra nights in hospital, sleep nurses' home visits to participant and partner at seven, 14 and 28 days and four months after starting CPAP

Control

Full explanation of need for and benefits of CPAP by sleep physician, 20‐minute video education programme, given mask to try for 20 minutes, titration of CPAP pressure overnight with following day discharge, nurses telephoned on days two and 21, reviewed in hospital at one, three and six months

Duration: 24 weeks

Outcomes

  • Machine usage (hours/night) at six/12

  • Cognitive function

  • Simple unprepared reaction time

  • Quality of life

  • Symptom score (in‐house questionnaire)

  • Mood

  • Sleep factors

  • Epworth Sleepiness Scale score

  • Maintenance of Wakefulness Test

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Each participant was randomly assigned with predetermined
balanced blocks generated by tossing a coin

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Single‐blind: 'Patients were blinded to the group to which they were allocated'

Not enough information available to ascertain awareness of CPAP machine usage

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

'Data were analysed on an intention‐to‐treat basis'

Hui 2000

Methods

Randomised, parallel‐group study

Participants

N = 108

Mean age: 45, Mean AHI: 48, All participants newly diagnosed with OSA

Inclusion criteria: diagnosis of OSA (AHI > 10 and subjective daytime sleepiness)

Interventions

Intervention

10‐Minute CPAP education programme by respiratory nurse, brochure on OSA and CPAP treatment in Chinese, short trial CPAP therapy with comfortable mask for 30 minutes, CPAP titration on second night of study by AutoSet, nursing support following day, follow‐up by nursing staff and physician at 1 and 3 months. Locally produced 15‐minute videotape, additional nurse led 15‐minute educational session, review by physicians at weeks one and two, respiratory nurse telephone call on days one and two, weeks one, two, four, eight and 12

Control

10‐Minute CPAP education programme by respiratory nurse, brochure on OSA and CPAP treatment in Chinese, short trial CPAP therapy with comfortable mask for 30 minutes, CPAP titration on second night of study by AutoSet, nursing support following day, follow‐up by nursing staff and physician at 1 and 3 months.

Study duration: 12 weeks

Outcomes

  • Mean pressure required

  • Machine usage (objective and participant reported)

  • At least four hours of CPAP use/night for at least 70% of nights/wk)

  • Quality of life

  • ESS

  • SAQLI

  • Cognitive function

Notes

91 participants had to purchase or rent their machines. 17 participants (10 in AS group and seven in BS group) qualified for state support

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Described as randomised; other information not available

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Not specified.

Participants provided subjective CPAP machine usage data

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Data were analysed on an intention‐to‐treat basis

Lewis 2006

Methods

Prospective, single‐blinded interventional study

Participants

N = 72

M/F: 62/10, Mean age: 51.4, Mean AHI control group: 42, All participants newly diagnosed with OSA

Inclusion criteria: diagnosis of OSA (based on home sleep study) and subjective daytime sleepiness

Interventions

Intervention

20‐Minute educational video about SAHS. Telephone interview by research assistant between days two and five after CPAP issued to identify early problems and advise. Extra appointment to see sleep physician within seven to 14 days after being issued CPAP. Further appointment with sleep physician at one, six and 12 months

Control

Participants provided telephone number for support within office hours. Sleep physician reviewed participants at one, six and 12 months

Study duration: 52 weeks

Outcomes

  • Machine usage

  • Withdrawal

  • Side effects

  • Satisfactions

Notes

Only 20/36 participants in the intervention group watched the educational video tape

Eight of the 17 defaulters returned machines at different times of the year and had negligible hours of use

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomly assigned using block tables

Allocation concealment (selection bias)

Low risk

'The sequence of group assignment was indeed concealed from the investigators undergoing the screening and assessments, especially those recording/analysing machine hours'

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Single‐blinded: participant unaware of what 'intensive' or standard support comprised

'The CPAP clock‐timers were hidden with a plastic strip. Patients were not informed about the timers, and all covers were intact at each review; both patients and those recording
clock‐timers were unaware of group allocation'

Incomplete outcome data (attrition bias)
All outcomes

High risk

Non‐completers not included in analysis of usage data

Meurice 2007a

Methods

Randomised parallel‐group trial 

Participants

N = 57

Mean age: 58, Mean AHI: 58

Inclusion criteria: AHI > 30, no prior treatment for OSA

Interventions

Intervention

Reinforced education by the homecare team: home visit by technician at installation and further visits for explanation at one week, one month and two and three months of treatment for repetition of education and problem solving

Reinforced education by prescriber: written material on CPAP use; explanation of OSA and CPAP with side effects; emphasis on importance of compliance with CPAP and detailed demonstration

Control

Standard education by the homecare network. Homecare visit to supply the CPAP machine, fit the mask and explain the technique of using the apparatus. CPAP mechanism and method of using the machine and mask were explained. Participant was encouraged to ask questions and could phone at any time to resolve problems

Reinforced education by prescriber: written material on CPAP use; explanation of OSA and CPAP with side effects; emphasis on importance of compliance with CPAP and detailed demonstration

Study duration: follow‐up to 52 weeks (intervention administered at outset of study). Data extracted at three months: 'During the remaining 9 months following the initial study design, there was no specific follow‐up protocol and patients benefited from the standard homecare surveillance recommended in the ANTADIR network, with a review every 3 months'

Outcomes

  • Machine usage

  • ESS

  • Quality of life (SF‐36)

  • Withdrawals

Notes

The study comprised four arms. We created four intervention/control comparisons and considered the effects of each as a separate study

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Described as randomised; other information not available

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not done

Incomplete outcome data (attrition bias)
All outcomes

High risk

‘One hundred thirty‐three patients were initially scheduled. However, complete initial data were obtained in only 112 patients who were definitively included in the study’

Meurice 2007b

Methods

Randomised parallel‐group trial 

Participants

N = 55

Mean age: 58, Mean AHI: 58

Inclusion criteria: AHI > 30, no prior treatment for OSA

Interventions

Intervention 

Reinforced education by the homecare team: home visit by technician at installation and further visits for explanation at one week, one month and two and three months of treatment for repetition of education and problem solving

Standard education by the prescriber

Control

Standard education by the homecare network. Homecare visit to supply the CPAP machine, fit the mask and explain the technique of using the apparatus. CPAP mechanism and method of using the machine and mask were explained. Participant was encouraged to ask questions and could phone at any time to resolve problems

Standard education by the prescriber

Study duration: follow‐up to 52 weeks (intervention administered at outset of study). Data extracted at three months: 'During the remaining 9 months following the initial study design, there was no specific follow‐up protocol and patients benefited from the standard homecare surveillance recommended in the ANTADIR network, with a review every 3 months'

Outcomes

  • Machine usage

  • ESS

  • Quality of life (SF‐36)

  • Withdrawals

Notes

The study comprised four arms. We created four intervention/control comparisons and considered the effects of each as a separate study

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Described as randomised; other information not available

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not done

Incomplete outcome data (attrition bias)
All outcomes

High risk

‘One hundred thirty‐three patients were initially scheduled. However, complete initial data were obtained in only 112 patients who were definitively included in the study’

Meurice 2007c

Methods

Randomised parallel‐group trial 

Participants

N = 55

Mean age: 58, Mean AHI: 58

Inclusion criteria: AHI > 30, no prior treatment for OSA

Interventions

Intervention 

Reinforced education by the homecare team: home visit by technician at installation and further visits for explanation at one week, one month and two and three months of treatment for repetition of education and problem solving

Reinforced education by prescriber: written material on CPAP use; explanation of OSA and CPAP with side effects; emphasis on importance of compliance with CPAP and detailed demonstration

Control

Reinforced education by the homecare team: home visit by technician at installation and further visits for explanation at one week, one month and two and three months of treatment for repetition of education and problem solving

Standard education by the prescriber

Study duration: follow‐up to 12 months (intervention administered at outset of study). Data extracted at three months: 'During the remaining 9 months following the initial study design, there was no specific follow‐up protocol and patients benefited from the standard homecare surveillance recommended in the ANTADIR network, with a review every 3 months'

Outcomes

  • Machine usage

  • ESS

  • Quality of life (SF‐36)

  • Withdrawals

Notes

The study comprised four arms. We created four intervention/control comparisons and considered the effects of each as a separate study

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Described as randomised; other information not available

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Not done

Incomplete outcome data (attrition bias)
All outcomes

High risk

‘One hundred thirty‐three patients were initially scheduled. However, complete initial data were obtained in only 112 patients who were definitively included in the study’

Meurice 2007d

Methods

Randomised parallel‐group trial 

Participants

N = 57

Mean age: 58, Mean AHI: 58

Inclusion criteria: AHI > 30, no prior treatment for OSA

Interventions

Intervention

Standard education by the homecare network. Homecare visit to supply the CPAP machine, fit the mask and explain the technique of using the apparatus. CPAP mechanism and method of using the machine and mask were explained. Participant was encouraged to ask questions and could phone at any time to resolve problems

Reinforced education by prescriber: written material on CPAP use; explanation of OSA and CPAP with side effects; emphasis on importance of compliance with CPAP and detailed demonstration

Control

Standard education by the homecare network. Homecare visit to supply the CPAP machine, fit the mask and explain the technique of using the apparatus. CPAP mechanism and method of using the machine and mask were explained. Participant was encouraged to ask questions and could phone at any time to resolve problems

Standard education by the prescriber

Study duration: follow‐up to 12 months (intervention administered at outset of study). Data extracted at three months: 'During the remaining 9 months following the initial study design, there was no specific follow‐up protocol and patients benefited from the standard homecare surveillance recommended in the ANTADIR network, with a review every 3 months'

Outcomes

  • Machine usage

  • ESS

  • Quality of life (SF‐36)

  • Withdrawals

Notes

The study comprised four arms. We created four intervention/control comparisons and considered the effects of each as a separate study

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Described as randomised; other information not available

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not done

Incomplete outcome data (attrition bias)
All outcomes

High risk

‘One hundred thirty‐three patients were initially scheduled. However, complete initial data were obtained in only 112 patients who were definitively included in the study’

Olsen 2012

Methods

Randomised parallel‐group study

Participants

N = 100

Intervention group: Age: 55.1, Male: 58.5%, ESS: 10.8, RDI: 36.2

Control group: Age: 57.8, Male: 71.7%, ESS: 11.1, RDI: 32.4

Inclusion criteria: OSA confirmed by polysomnography, age ≥ 18, naive to CPAP

Exclusion criteria: need for bi‐level ventilation, failed to complete CPAP titration, severe depression

Interventions

Intervention

Three sessions of CPAP‐specific Motivational Interview Nurse Therapy (MINT) one month apart. Each session lasted approximately 30 minutes. In addition, all participants received standard one‐on‐one 45‐minute education session conducted on the day of CPAP titration. Participants were followed up at two to four weeks by physician and at two months by a nurse. A questionnaire and a machine meter data on adherence were obtained at one, three and 12 months

Control

Standard one‐on‐one 45‐minute education session conducted on the day of CPAP titration. Participants were followed up at two to four weeks by physician and at two months by a nurse

Study duration: 52 weeks

Outcomes

  • CPAP acceptance and adherence

  • FOSQ

  • Self‐efficacy measure for sleep apnoea

  • ESS

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomly assigned using envelopes with group allocation; no blocking or stratification used

Allocation concealment (selection bias)

Low risk

'...opaque, unlabelled envelopes...shuffled by a research assistant...placed into an allocation box held in a secured clinic area.' Administrative officers not otherwise involved in the study withdrew an envelope and booked the participant's future appointments accordingly

Blinding (performance bias and detection bias)
All outcomes

High risk

Participants and intervention nurses were not blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

'The adherence analyses were by intent‐to‐treat...The multiple imputation method for substitution missing data was used...All univariate and bivariate statistical assumptions were met'

Parthasarathy 2012

Methods

Randomised parallel‐group open‐label

Participants

N = 39

All veterans

Intervention group: N = 22, Age: 53 ± 14, Men: 100%, BMI: 35, AHI: 36.7

Control group: N = 17, Age: 50 ± 14, BMI: 33, Men: 100%, AHI: 37.5

Inclusion criteria: new diagnosis of OSA, AHI > five, full night or split night polysomnography, Age: 21 to 85, no sedative medications used

Exclusion criteria: central or complex sleep apnoea, requirement of oxygen or Bi‐PAP, unstable medical co‐morbidities, irregular lifestyle pattern, excess alcohol use

Interventions

Intervention

Peer‐driven system (PBS); trained peers with OSA and good CPAP adherence record were paired with newly diagnosed participants over three months. During two face‐to‐face sessions and eight telephone‐based conversations, trained peers shared their experiences on coping strategies with CPAP, knowledge of perceived vulnerabilities of untreated OSA, motivated participants and promoted methods for improving efficacy of CPAP

Control group

Usual care: CPAP initiation and education class, participants were asked to send CPAP adherence 'smart cards' and were followed up at one and three months

Study duration: 12 weeks

Outcomes

  • Participant ratings of acceptability of PBS

  • CPAP adherence

  • Functional Outcomes of Sleep Questionnaire (FOSQ)

  • Vigilance, self‐efficacy and participant activation

  • Nasal congestion score

Notes

Additional information on study methods and mean CPAP adherence obtained from the study author

These data were available from a pilot study. Larger trial is currently being undertaken

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation was accomplished by computer‐generated assignment placed in sealed envelopes that were opened in a predetermined sequence of numbered and sealed envelopes

Allocation concealment (selection bias)

Low risk

See above

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Observers who evaluated outcomes and care providers were blinded to group allocation. Participants were not blinded to the intervention and were aware of CPAP adherence monitoring

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Two of 17 participants in the control group lost to follow‐up versus zero in the intervention group

No information on how this attrition was dealt with

Richards 2007

Methods

Randomised, parallel‐group trial  

Participants

N = 100

M/F: 86/15, Mean age: 56, RDI: 26, ESS: 10.5

Inclusion criteria: newly diagnosed with OSA

All participants referred for CPAP treatment. 109 screened and nine refused to participate  

Interventions

Intervention

Cognitive‐behavioural therapy. Two one‐hour group sessions; slide presentation on sleep, OSA and treatment. CPAP machine on display and relaxation techniques in the event of anxiety caused by wearing CPAP mask

Participants also benefited from video presentation with emphasis on perseverance with treatment and educational pamphlet made available   

Control

Treatment as usual: one standardised group education session; explanation of CPAP titration process; familiarisation with equipment used and procedure to be followed on the titration night. Explanation of side effects, all participants strongly encouraged to contact staff to obtain relevant help and support. Participants assessed and fitted with comfortable mask to be worn during titration

Study duration: CBT over course of one week before home treatment with CPAP. Assessment of CPAP made after four weeks

Outcomes

  • Machine usage

  • Withdrawal

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'...a sequence generated with a blocking factor of 4'

Allocation concealment (selection bias)

Low risk

'An investigator not involved with recruitment or provision of treatment independently randomised participants using a sequence generated with a blocking factor of 4. Allocation concealment was achieved with sequentially numbered, opaque, sealed envelopes'

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Not possible/attempted for participants; assessors and technicians not informed of treatment groups

'Staff members were blinded to which group participants had been allocated and the 3 usual CPAP therapists strictly adhered to a script'

Participants not informed that machine usage would be monitored

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

High attrition rate in control group (17/48 refused to take CPAP home)

'Analysis was by intention to treat, and we measured hours
of usage of CPAP at 28 days'

Roecklein 2010

Methods

Randomised parallel‐group study

Participants

N = 30

Age: 46, Male sex: 30%, African Americans: 66.7%, AHI: 44, RDI: 56, ESS: 11.6, BMI: 42

Inclusion criteria: age 18 to 65, CPAP naive, reported intent to use CPAP; other sleep, psychiatric or health problems were not exclusion criteria

Interventions

Intervention

Written personalised feedback report, including detailed information on severity of the disease, self‐reported daytime sleepiness, individually estimated risk of adverse health outcome and risk of motor vehicle accident, all compared with normative data. Feedback addressed barriers to using CPAP, ambivalence about treatment and difficulties of behaviour change and promoted self‐efficacy and personal responsibility for choosing to use CPAP

Control

Written information from the American Academy of Sleep Medicine on OSA, Snoring and PAP therapy for OSA

Study duration: three months

Outcomes

  • Objective CPAP usage (total hours, average hours/night, number of sessions)

  • Self‐reported CPAP usage

Notes

Participants were not provided machines but obtained them 'naturalistically', most commonly through insurance. Most participants were low‐income African Americans

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Information not available

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

'Physicians were blind to study participation and participants were blind to their study condition.' Patients were aware that CPAP usage was monitored. Despite intended blinding, it is likely that participants would have been able to distinguish the two interventions

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Only two incidents of missing data in each group. However, in addition, participants who took longer to obtain machines (n = 5 in control group and n = 2 in intervention group did not obtain devices by two weeks) were included from the start and had CPAP usage recorded as 0 hours per session. It is possible that financial burden prevented some participants from acquiring CPAP machines in a timely fashion

Schiefelbein 2005

Methods

Randomised, parallel‐group trial. The study presented was a secondary analysis on a subset of participants from the parent study (N = 122)

Participants

N = 51 (intervention: 32; placebo: 19)

26 M

Inclusion criteria: identified as non‐adherent CPAP users from a parent study (N = 122); all used CPAP for < four hours per night

Interventions

Intervention

Internet‐based application aimed at encouraging problem solving and preparedness in application of CPAP

Control

Internet‐based application similar in format to intervention but directed activities in neutral health topics (vitamin intake)

Study duration: 16 weeks

Outcomes

  • Problem‐solving confidence

  • Preparedness for home care

  • Evaluation of website

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation schedule with gender as a stratification variable

Allocation concealment (selection bias)

Unclear risk

Information not provided

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Single‐blind: Participants in the control group were given different content delivered in similar way to intervention

Outcome assessors not aware of assignment of treatment groups

No information on whether participants were aware that CPAP usage was being monitored

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Data for all participants presented

Smith 2006

Methods

Randomised parallel‐group trial

Participants

N = 19

Mean age: 63

Inclusion criteria: non‐adherent with CPAP for three months, after initial education on CPAP use and supplemental audiotaped/videotaped reinforcement at two and four weeks

Interventions

Intervention

Two‐way telehealth sessions mediated by video link‐up through phone line. Research nurse emphasised nightly, bedtime routine for CPAP. After standardised protocols, nurse visually assessed participant, guided correct CPAP routine and determined whether the CPAP mask fits properly. Nurse described consequences of non‐adherence and managing barriers to CPAP use. Benefits of nightly CPAP use for general health were emphasised

Control

Two‐way telehealth sessions mediated by video link‐up through phone line. Protocols drawn up to mimic content delivered to intervention group. Instead of CPAP‐related information, participants given content on vitamin intake

Study duration: 12 weeks of scheduled telehealth sessions

Outcomes

  • N adhering to CPAP for longer than four hours/night

  • Participant satisfaction

  • Withdrawal

Notes

Non‐adherence in the study defined as less than four hours of CPAP use per night for fewer than nine of 14 consecutive nights’ use

TJL emailed for details of randomisation and outcome data 12/09/2008. Carol Smith responded 15/09/2008

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'...randomised and done via computer software generated random assignment’

Allocation concealment (selection bias)

Low risk

'...allocation sequence and treatment group assignment concealed from investigators conducting the screening and ongoing assessments'

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Single‐blind; nursing interventionist staff aware of different content delivered by video link‐up

Machine usage was measured via smart card by blinded sleep lab personnel. Information on participants' awareness of CPAP machine usage was insufficient for us to determine how this might have affected the study

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All participants finished follow‐up and contributed to data on adherence. Two satisfaction surveys were not submitted (one from each group)

Smith 2009

Methods

Randomised parallel‐group trial

Participants

N = 97

Mean age: 63.4, Male sex: 55%, Mean AHI: Intervention group: 52.3, Control group: 47.3

Inclusion criteria: new diagnosis of OSA, age ≥ 18, AHI ≥ 20

Exclusion criteria: positive screening for drug or alcohol abuse, depression requiring hospitalisation

Interventions

All participants received usual education on OSA and demonstration of CPAP equipment

Intervention

Audiotaped music along with softly spoken directions on relaxation techniques and habit‐promoting instructions for using CPAP nightly. Participants received information packet, which included CPAP use reminder placard, handouts on benefits of CPAP adherence and health consequences of poor compliance, four‐week diary for recording experience with CPAP

Control group

Audiotaped music along with spoken information about vitamins. Information packet was the same in format and length as the intervention group, but content was on vitamins

Study duration: 24 weeks

Outcomes

  • N adhering to CPAP (≥ four hours/d and ≥ nine of 14 nights)

  • Self‐reported audiotape/diary use

  • Participant satisfaction

  • Withdrawal

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Participants randomly assigned using computerised random assignment programme

Allocation concealment (selection bias)

Low risk

Participants recruited by 'nurses who had no knowledge of group assignment'

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Single‐blind; '...placebo intervention was used to mimic the daily activities in the experimental treatment...' CPAP usage was measured via smart cards by blinded personnel.

Nurses administering experimental or placebo control interventions aware of different content of these interventions. Unclear whether participants were aware of machine usage monitoring. Personnel analysing data on compliance were blind to allocation of treatment

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Intention‐to‐treat analysis but imbalanced N of dropouts: Intervention group: 11/55 (20%), Control group: 13/42 (31%) at six months. Unclear whether reasons for dropouts were balanced across groups

Sparrow 2010

Methods

Randomised parallel‐group trial

Participants

N = 250

Median age: 55.0 years, 82% Men, Median BMI: 35.1

Intervention group: AHI: 36, ESS: 10

Conrol group: AHI: 40.5, ESS: 11

Inclusion criteria: age 18 to 80 years, AHI > 10

Exclusion criteria: not reported

Interventions

Intervention

Automated telephone‐linked communication system adapted for CPAP (TLC‐CPAP), designed around the concepts of motivational interviewing. Digitised human speech was used, and participants were communicating with it via touch tone keypad of their telephones. The TLC‐CPAP content included assessment of the participant's experience with CPAP, self‐reported machine use, feedback and counselling to enhance adherence and side effect management. Participants were required to make weekly calls to TLC‐CPAP during the first month and monthly thereafter. Printed reports were sent to the participant's physician. Participants were encouraged to contact physician directly if any excessive symptoms or side effects of treatment encountered

Control

'Attention placebo control' group received general education on a variety of health topics via a telephone‐linked communication (TLC) system. Participants were required to make calls on the same schedule as the intervention group

Study duration: 52 weeks

Outcomes

  • Machine usage (data downloaded from memory cards or by direct interrogation of CPAP devices)

  • Adherence to CPAP (> four hours/night)

  • Association between CPAP use and FOSQ, sleep symptoms, CES‐D, visual reaction time

  • Self‐efficacy index

  • Decisional balance index

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'...randomisation stratified by sex, age and AHI using a randomised block design'

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Blinding of participants attempted by developing an 'attention placebo control group'. However, given the nature of the intervention, participants may have been aware of group assignment. Participants in the intervention group self‐reported frequency and duration of CPAP usage. It is unclear whether participants in the control group were aware of CPAP usage monitoring

'...all data were collected by research assistants blind to group assignment'. Unclear whether the same applied to outcome assessors

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Data were analysed by intention to treat. Multiple‐imputation procedure was implemented to account for missing data in the outcome of CPAP use due to loss to follow‐up. 20/124 in the intervention group and 15/126 in the control group lost to follow‐up at 12 months

Stepnowsky 2007

Methods

Randomised parallel‐group trial        

Participants

N = 45 (40 presented as baseline and completed)

Mean age: 59, Male: 98%, AHI: 39, ESS: 12.6

Inclusion criteria: AHI ≥ 15, no prior CPAP treatment, stable sleep environment

Exclusion criteria: allergies/sensitivity to mask or mask material, previous use of any other PAP device (e.g. bi‐level PAP, auto‐adjusting PAP), current use of prescribed supplemental oxygen or significant comorbid medical conditions that could interfere with daily use of CPAP

Interventions

Intervention

Review of compliance and efficacy data. Monitored information garnered as objective compliance data and subjective reports of usage. Follow‐up tailored to how CPAP used by participants. Details on how many total hours the PAP unit was used each night at therapeutic pressure. Efficacy data consisted of the amount of mask leakage (L/s) and the AHI (total number of apnoeas and hypopnoeas per hour of sleep)

Control

Telephone call from staff one week after CPAP initiation and office follow‐up visit at one month. Participants encouraged to call clinic any time with problems or concerns 

Study duration: eight weeks

Outcomes

  • Machine usage

  • ESS

  • Withdrawals

  • Depression

  • Quality of life (Functional Outcomes of Sleep Questionnaire)

  • AHI

Notes

TJL emailed for randomisation 12/09/2008. Carl Stepnowsky responded 15/09/2008

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'...we used the uniform random number generator in R to select all sequences of 4 randomly with equal probability so that the occurrence of 3 in a row being assigned to the same group would be extremely rare'

Allocation concealment (selection bias)

Low risk

'The randomisation scheme was concealed until the time at which the intervention was assigned. The randomisation scheme was generated by the project statistician and carried out by research staff immediately after the informed consent procedure and the completion of the baseline questionnaires'

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Participants in both groups received a monitoring unit

All participants likely to be aware that CPAP usage was measured

Incomplete outcome data (attrition bias)
All outcomes

High risk

‘There were five CPAP “rejectors,” or patients who decided within the first day or two that they did not want to pursue CPAP as the primary treatment for their OSA. Our study did not have a “run‐in” period, which could have helped identify these patients prior to the intervention’

Taylor 2006

Methods

Randomised parallel‐group trial

Participants

N = 133

Mean age: 45, ESS: 14, CPAP pressure: 8.9

All participants were service or ex‐service personnel in USA

Inclusion criteria: 18 to 64 years; RDI ≥ five; English speaking

Exclusion criteria: acute illness, hospitalised participants, significant nocturnal hypoxaemia, ESS < eight, disorder interfering with ability to use computer at home (i.e. blindness), major mental illness, physical disability that interfered with optimal use of computer, prior use of CPAP, undergoing concurrent therapy for OSA (MAD, surgery)

Interventions

Intervention

Education on first day; film on OSA and CPAP; instruction in use of CPAP; encouragement to attend sleep clinic. Computer programme (Health Buddy) delivering questions on a daily basis; responses were monitored by sleep medicine practitioners. If persistent high‐risk answers given, this prompted a sleep practitioner to contact the participant within 24 hours

Control

Education on first day; film on OSA and CPAP; instruction in use of CPAP; encouragement to attend sleep clinic. Follow‐up at one month with a scheduled clinic visit; telephone consultation

Study duration: four weeks

Outcomes

  • Machine usage

  • FOSQ

  • Participant satisfaction questionnaire

  • General perceived self‐efficacy

  • Self‐efficacy scale to use CPAP

  • Psychometric analysis

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random numbers. Participants stratified according to age, gender and severity of symptoms

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not undertaken

'Each day, the patient was greeted with three questions regarding reported hours of nasal CPAP use...'

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Information not available

Wang 2011a

Methods

Randomised parallel‐group study

Participants

N = 76

Intervention group: Male: 89.5%, AHI: 35.7, ESS: 13.4, Control group: Male: 81.6%, AHI: 38.5, ESS: 13.9

Incusion criteria: new diagnosis of OSA, AHI ≥ 10, above elementary school education, 'conscious mind and able to communicate clearly'

Exclusion criteria: personal or family history of mental illness, drug or alcohol abuse, severe cognitive impairment, 'concurrent oncologic or psychiatric diseases'

Interventions

Intervention

Three nights of CPAP titration in the first week, four‐hour group education session on OSA and CPAP in the first week, participants were given a brochure describing benefits of CPAP and CD containing a 20‐minute video demonstrating how to optimise CPAP treatment, 24‐hour consultation telephone line to the sleep nurses was available

Control

One night of CPAP titration in the hospital in the first week

Study duration: 12 weeks

Outcomes

  • N adhering to CPAP (≥ four hours/d and ≥ nine of 14 nights)

  • CPAP usage (hours/d, hours/d used, % days with compliance ≥ four hours)

  • ESS

  • Sleep quality (Pittsburgh)

  • Anxiety (STAI)

  • HADS‐D score

Notes

The study comprised four treatment arms: three intervention groups and one control group. We consider the effects of the three intervention arms as separate studies

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'The patients were randomly assigned...by block randomisation'

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not performed

Information on participants' awareness of CPAP machine usage monitoring not available

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

'The patients' CPAP adherence rates and dropout rates were analysed on an intention‐to‐treat basis'

Wang 2011b

Methods

Randomised parallel‐group study

Participants

N = 76

Intervention group: Male: 76.3%, AHI: 41.2, ESS: 14.7

Control group: Male: 81.6%, AHI: 38.5, ESS: 13.9

Incusion criteria: new diagnosis of OSA, AHI ≥ 10, above elementary school education, 'conscious mind and able to communicate clearly'

Exclusion criteria: personal or family history of mental illness, drug or alcohol abuse, severe cognitive impairment, 'concurrent oncologic or psychiatric diseases'

Interventions

Intervention

One night of CPAP titration in the hospital, 12 × 40 minute group Progressive Muscle Relaxation (PMR) practice sessions over 12 weeks, one per week. Self‐practice of PMR before each CPAP treatment. Brochure and CD with a guide for PMR practice at home

Control

One night of CPAP titration in the hospital in the first week

Study duration: 12 weeks

Outcomes

  • N adhering to CPAP (≥ four hours/d and ≥ nine of 14 nights)

  • CPAP usage (hours/d, hours/d used, % days with compliance ≥ four hours)

  • ESS

  • Sleep quality (Pittsburgh)

  • Anxiety (STAI)

  • HADS‐D score

Notes

The study comprised four treatment arms: three intervention groups and one control group. We consider the effects of the three intervention arms as separate studies

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'The patients were randomly assigned...by block randomisation'

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not performed

Information on participants' awareness of CPAP machine usage monitoring not available

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

'The patients' CPAP adherence rates and dropout rates were analysed on an intention‐to‐treat basis'

Wang 2011c

Methods

Randomised parallel‐group study

Participants

N = 76

Intervention group: Male: 81.6, AHI: 43.1, ESS: 14.5

Control group: Male: 89.5%, AHI‐35.7, ESS: 13.4

Incusion criteria: new diagnosis of OSA, AHI ≥ 10, above elementary school education, 'conscious mind and able to communicate clearly'

Exclusion criteria: personal or family history of mental illness, drug or alcohol abuse, severe cognitive impairment, 'concurrent oncologic or psychiatric diseases'

Interventions

Intervention

Three nights of CPAP titration in the hospital. Combination of interventions as in Education and PMR group (see above)

Control

The control for this intervention was the intervention arm of Wang 2011a

Study duration: 12 weeks

Outcomes

  • N adhering to CPAP (≥ four hours/d and ≥ nine of 14 nights)

  • CPAP usage (hours/d, hours/d used, % days with compliance ≥ four hours)

  • ESS

  • Sleep quality (Pittsburgh)

  • Anxiety (STAI)

  • HADS‐D score

Notes

The study comprised four treatment arms: three intervention groups and one control group. We consider the effects of the three intervention arms as separate studies. In this study, for the combined intervention, Education + PMR, the control group was Education

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'The patients were randomly assigned...by block randomisation'

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not performed

Information on participants' awareness of CPAP machine usage monitoring not available

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

'The patients' CPAP adherence rates and dropout rates were analysed on an intention‐to‐treat basis'

Wang 2011d

Methods

Randomised parallel‐group study

Participants

N = 76

Intervention group: Male: 81.6, AHI: 43.1, ESS: 14.5

Control group: 76.3%, AHI: 41.2, ESS: 14.7

Inclusion criteria: new diagnosis of OSA, AHI ≥ 10, above elementary school education, 'conscious mind and able to communicate clearly'

Exclusion criteria: personal or family history of mental illness, drug or alcohol abuse, severe cognitive impairment, 'concurrent oncologic or psychiatric diseases'

Interventions

Intervention

Three nights of CPAP titration in the hospital. Combination of interventions as in Education + PMR group (see above)

Control

The control for this intervention was the intervention arm of Wang 2011b

Study duration: 12 weeks

Outcomes

  • N adhering to CPAP (≥ four hours/d and ≥ nine of 14 nights)

  • CPAP usage (hours/d, hours/d used, % days with compliance ≥ four hours)

  • ESS

  • Sleep quality (Pittsburgh)

  • Anxiety (STAI)

  • HADS‐D score

Notes

The study comprised four treatment arms: three intervention groups and one control group. We consider the effects of the three intervention arms as separate studies. In this study, for the combined intervention, Education + PMR, the control group was PMR

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'The patients were randomly assigned...by block randomisation'

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not performed

Information on participants' awareness of CPAP machine usage monitoring not available

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

'The patients' CPAP adherence rates and dropout rates were analysed on an intention‐to‐treat basis'

Wiese 2005

Methods

Randomised, unblinded parallel‐group trial

Participants

N = 93

Mean age: 48, BMI: 38, Mean duration of symptoms: 5.4 years, % smokers (treatment: 26%; control: 49%), Mean AHI: 9, ESS: 13

Inclusion criteria: > 20 years; RDI > four; newly diagnosed OSAHS

Exclusion criteria: not reported

Interventions

Intervention

During initial visit, participants received explanations of OSA and CPAP by physician and respiratory therapist. Short instructional video (15‐minute tape of interview between two 'blue collar' workers discussing what CPAP felt like and how it helped them)

Control

During initial visit, participants received explanations of OSA and CPAP by physician and respiratory therapist. Control group members were interviewed

Both groups received instruction at outset on using CPAP

Study duration: four weeks

Outcomes

  • Machine usage

  • Attendance at outpatient clinic/withdrawal

  • ESS

  • SAQLI

Notes

Not able to assess machine usage, as 13 of the 57 participants who returned for their one‐month clinic visit had
unusable machine‐recorded data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Described as randomised; blocks of 10 to ensure balanced group design

Allocation concealment (selection bias)

Unclear risk

Information not available

Blinding (performance bias and detection bias)
All outcomes

High risk

Not undertaken

Information on participants' awareness of CPAP machine usage was insufficient for us to determine how this might have affected the study

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Information not available

AHI: Apnoea Hypopnoea Index; BiPAP: Bi‐level positive airway pressure; CPAP: Continuous positive airway pressure; ESS: Epworth Sleepiness Scale; FOSQ: Functional Outcomes of Sleep Questionnaire (quality of life instrument); OSA: Obstructive sleep apnoea; RDI: Respiratory Disturbance Index; SAQLI: Sleep Apnoea Quality of Life Index.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Damjanovic 2009

Allocation to the standard or intensive support group was based on proximity of participant's address to the sleep centre, and no randomisation occurred. Participants were randomly assigned only to APAP or CPAP treatment. This unpublished information was obtained from the study authors

Fletcher 1991

Cross‐over study

Gupta 2011

Implemented intervention could not be classified as supportive, educational, psychological or behavioural

Hirschowitz 2006

Participants randomly assigned to CPAP treatment or no treatment

Kajaste 2004

CBT programme given before randomisation to CPAP

Klein 2010

Excluded for the same reasons as Damjanovic 2009

Marshall 2003

Based on description of the study, it is unlikely that randomisation took place. No contact details of study authors available; therefore not possible to obtain further clarification on the trial design

Shaikh 2009

Data for only 19 of 128 enrolled participants analysed and reported

Signes‐Costa 2005

Clinical review conducted by different practitioners. No systematic intervention that is educational or behavioural in nature

Trupp 2011

No control group. Participants randomly assigned to positively or negatively framed education

Wenzel 2008

Participants randomly assigned to immediate or delayed CPAP prescription

Characteristics of studies awaiting assessment [ordered by study ID]

Bartlett 2010

Methods

Randomised parallel‐group study

Participants

N = 206

Intervention group: Age: 49, Male sex: 70%, AHI: 30.4, ESS: 12.0, BM: 35.8

Control group: Age: 47, Male sex: 72%, AHI: 39.9, ESS: 12, BMI: 34.4

Exclusion criteria: poor fluency in English and previous use of CPAP

Interventions

Intervention

30‐Minute group education session on sleep, OSA, risks of untreated OSA and CPAP treatment. CBT session including slides on health/social benefits of using CPAP and video of real‐life successful CPAP users. CBT session was delivered to a group of three or four participants

Control

Same 30‐minute group education session on sleep, OSA and CPAP usage. Social reciprocity consisting of afternoon tea served while participants watched a video of a patient undergoing diagnostic and CPAP studies

Study duration: six months

Outcomes

  • CPAP usage (hours/night and % using CPAP ≥ four hours/d)

  • Predictors of CPAP adherence

  • N of withdrawals

Notes

Inconsistency of preliminary data on CPAP adherence reported in an abstract form (e.g. SE of mean CPAP adherence difference derived from CI differs 100 times from that calculated from SD). Further characteristics of intervention and control  groups required

Information from the study authors that final withdrawal figures are different from those initially reported

The study has been submitted for journal publication, and further information may be available

Fanfulla 2008

Methods

Randomised parallel‐group

Participants

N = 20

Obese, OSA patients

Other baseline details not available

Inclusion criteria not available

Interventions

Intervention

Tele‐assisted rehabilitation programme consisting of individualised exercise programme to lose weight and monitor CPAP compliance. Regular phone call interview every two weeks to assess OSA symptoms, problems with CPAP, adherence to exercise programme and weight control

Control

Standard care, otherwise not specified

Study duration: six months

Outcomes

  • Machine usage: no data available

  • ESS: groups not matched

  • Reduction of BMI

  • Level of daily exercise

Notes

DRW emailed for further study information 30/06/2012

Peach 2003

Methods

Randomised parallel‐group

Participants

N = not specified

Baseline details not available

Inclusion criteria: newly diagnosed OSA

Interventions

All participants underwent titration at baseline. Fixed‐pressure CPAP was used throughout the study    

Intervention: self‐monitoring group

Control: non–self‐monitoring group

Study duration: not enough information presented on duration of study

Outcomes

  • AHI

  • Machine usage

Notes

TJL emailed for study information 12/09/2008

Data and analyses

Open in table viewer
Comparison 1. Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Machine usage (hours/night) Show forest plot

13

803

Mean Difference (IV, Random, 95% CI)

0.82 [0.36, 1.27]

Analysis 1.1

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 1 Machine usage (hours/night).

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 1 Machine usage (hours/night).

2 Machine usage, sensitivity analysis: excluding participants aware of machine usage monitoring Show forest plot

6

378

Mean Difference (IV, Fixed, 95% CI)

1.07 [0.61, 1.52]

Analysis 1.2

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 2 Machine usage, sensitivity analysis: excluding participants aware of machine usage monitoring.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 2 Machine usage, sensitivity analysis: excluding participants aware of machine usage monitoring.

3 Machine usage, sensitivity analysis: adherence in control group < four hours/night Show forest plot

8

471

Mean Difference (IV, Fixed, 95% CI)

1.36 [0.96, 1.76]

Analysis 1.3

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 3 Machine usage, sensitivity analysis: adherence in control group < four hours/night.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 3 Machine usage, sensitivity analysis: adherence in control group < four hours/night.

4 N deemed adherent (≥ four hours/night) Show forest plot

4

268

Odds Ratio (M‐H, Fixed, 95% CI)

2.06 [1.22, 3.47]

Analysis 1.4

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 4 N deemed adherent (≥ four hours/night).

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 4 N deemed adherent (≥ four hours/night).

5 Epworth Sleepiness Scale scores Show forest plot

8

501

Mean Difference (IV, Random, 95% CI)

‐0.60 [‐1.81, 0.62]

Analysis 1.5

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 5 Epworth Sleepiness Scale scores.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 5 Epworth Sleepiness Scale scores.

6 Quality of life: Functional Outcomes of Sleep Questionnaire Show forest plot

2

70

Mean Difference (IV, Fixed, 95% CI)

0.98 [‐0.84, 2.79]

Analysis 1.6

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 6 Quality of life: Functional Outcomes of Sleep Questionnaire.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 6 Quality of life: Functional Outcomes of Sleep Questionnaire.

7 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.7

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 7 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI).

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 7 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI).

8 Mood Show forest plot

3

312

Mean Difference (IV, Fixed, 95% CI)

‐0.94 [‐1.55, ‐0.33]

Analysis 1.8

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 8 Mood.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 8 Mood.

8.1 HAD Scale for Anxiety

1

80

Mean Difference (IV, Fixed, 95% CI)

‐1.10 [‐2.95, 0.75]

8.2 HAD Scale for Depression

3

232

Mean Difference (IV, Fixed, 95% CI)

‐0.93 [‐1.57, ‐0.28]

9 Withdrawals Show forest plot

12

903

Odds Ratio (M‐H, Fixed, 95% CI)

0.65 [0.44, 0.97]

Analysis 1.9

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 9 Withdrawals.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 9 Withdrawals.

10 AHI on treatment Show forest plot

2

115

Mean Difference (IV, Fixed, 95% CI)

‐0.07 [‐1.62, 1.48]

Analysis 1.10

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 10 AHI on treatment.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 10 AHI on treatment.

11 Maintenance of Wakefulness Test (MWT) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.11

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 11 Maintenance of Wakefulness Test (MWT).

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 11 Maintenance of Wakefulness Test (MWT).

Open in table viewer
Comparison 2. Educational interventions + CPAP versus usual care + CPAP

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Machine usage (hours/night) Show forest plot

7

508

Mean Difference (IV, Fixed, 95% CI)

0.60 [0.27, 0.93]

Analysis 2.1

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 1 Machine usage (hours/night).

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 1 Machine usage (hours/night).

2 N deemed adherent (≥ four hours/night) Show forest plot

3

285

Odds Ratio (M‐H, Fixed, 95% CI)

1.80 [1.09, 2.95]

Analysis 2.2

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 2 N deemed adherent (≥ four hours/night).

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 2 N deemed adherent (≥ four hours/night).

3 Epworth Sleepiness Scale scores Show forest plot

5

336

Mean Difference (IV, Fixed, 95% CI)

‐1.17 [‐2.07, ‐0.26]

Analysis 2.3

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 3 Epworth Sleepiness Scale scores.

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 3 Epworth Sleepiness Scale scores.

4 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 2.4

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 4 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI).

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 4 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI).

5 HAD Scale for Depression Show forest plot

2

152

Mean Difference (IV, Fixed, 95% CI)

‐0.52 [‐1.25, 0.22]

Analysis 2.5

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 5 HAD Scale for Depression.

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 5 HAD Scale for Depression.

6 Withdrawal Show forest plot

8

683

Odds Ratio (M‐H, Fixed, 95% CI)

0.67 [0.45, 0.98]

Analysis 2.6

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 6 Withdrawal.

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 6 Withdrawal.

Open in table viewer
Comparison 3. Behavioural therapy + CPAP versus control + CPAP

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Machine usage (hours/night) Show forest plot

6

584

Mean Difference (Random, 95% CI)

1.44 [0.43, 2.45]

Analysis 3.1

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 1 Machine usage (hours/night).

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 1 Machine usage (hours/night).

2 Sensitivity analysis: excluding participants aware of machine usage monitoring Show forest plot

5

Mean Difference (Fixed, 95% CI)

1.54 [0.99, 2.09]

Analysis 3.2

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 2 Sensitivity analysis: excluding participants aware of machine usage monitoring.

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 2 Sensitivity analysis: excluding participants aware of machine usage monitoring.

3 N deemed adherent (≥ four hours/night) Show forest plot

3

358

Odds Ratio (M‐H, Fixed, 95% CI)

2.23 [1.45, 3.45]

Analysis 3.3

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 3 N deemed adherent (≥ four hours/night).

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 3 N deemed adherent (≥ four hours/night).

4 Epworth Sleepiness Scale score Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 3.4

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 4 Epworth Sleepiness Scale score.

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 4 Epworth Sleepiness Scale score.

5 Quality of life: Functional Outcomes of Sleep Questionnaire Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 3.5

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 5 Quality of life: Functional Outcomes of Sleep Questionnaire.

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 5 Quality of life: Functional Outcomes of Sleep Questionnaire.

6 Withdrawal Show forest plot

5

609

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.57, 1.25]

Analysis 3.6

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 6 Withdrawal.

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 6 Withdrawal.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Forest plot of comparison: 1 Increased psychological and/or practical support during follow‐up + CPAP versus usual care + CPAP, outcome: 1.1 Machine usage (hours/night)—first arm/parallel studies.
Figuras y tablas -
Figure 3

Forest plot of comparison: 1 Increased psychological and/or practical support during follow‐up + CPAP versus usual care + CPAP, outcome: 1.1 Machine usage (hours/night)—first arm/parallel studies.

Forest plot of comparison: 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, outcome: 1.3 Machine usage, sensitivity analysis: adherence in control group =< four hours/night.
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, outcome: 1.3 Machine usage, sensitivity analysis: adherence in control group =< four hours/night.

Funnel plot of comparison: 1 Increased practical support and encouragement + CPAP versus usual care + CPAP, outcome: 1.1 Machine usage (hours/night).
Figuras y tablas -
Figure 5

Funnel plot of comparison: 1 Increased practical support and encouragement + CPAP versus usual care + CPAP, outcome: 1.1 Machine usage (hours/night).

Forest plot of comparison: 2 Educational interventions + CPAP versus usual care + CPAP, outcome: 2.1 Machine usage (hours/night).
Figuras y tablas -
Figure 6

Forest plot of comparison: 2 Educational interventions + CPAP versus usual care + CPAP, outcome: 2.1 Machine usage (hours/night).

Forest plot of comparison: 4 Behavioural therapy + CPAP versus control + CPAP, outcome: 4.1 Machine usage.
Figuras y tablas -
Figure 7

Forest plot of comparison: 4 Behavioural therapy + CPAP versus control + CPAP, outcome: 4.1 Machine usage.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 1 Machine usage (hours/night).
Figuras y tablas -
Analysis 1.1

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 1 Machine usage (hours/night).

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 2 Machine usage, sensitivity analysis: excluding participants aware of machine usage monitoring.
Figuras y tablas -
Analysis 1.2

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 2 Machine usage, sensitivity analysis: excluding participants aware of machine usage monitoring.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 3 Machine usage, sensitivity analysis: adherence in control group < four hours/night.
Figuras y tablas -
Analysis 1.3

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 3 Machine usage, sensitivity analysis: adherence in control group < four hours/night.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 4 N deemed adherent (≥ four hours/night).
Figuras y tablas -
Analysis 1.4

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 4 N deemed adherent (≥ four hours/night).

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 5 Epworth Sleepiness Scale scores.
Figuras y tablas -
Analysis 1.5

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 5 Epworth Sleepiness Scale scores.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 6 Quality of life: Functional Outcomes of Sleep Questionnaire.
Figuras y tablas -
Analysis 1.6

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 6 Quality of life: Functional Outcomes of Sleep Questionnaire.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 7 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI).
Figuras y tablas -
Analysis 1.7

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 7 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI).

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 8 Mood.
Figuras y tablas -
Analysis 1.8

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 8 Mood.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 9 Withdrawals.
Figuras y tablas -
Analysis 1.9

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 9 Withdrawals.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 10 AHI on treatment.
Figuras y tablas -
Analysis 1.10

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 10 AHI on treatment.

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 11 Maintenance of Wakefulness Test (MWT).
Figuras y tablas -
Analysis 1.11

Comparison 1 Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP, Outcome 11 Maintenance of Wakefulness Test (MWT).

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 1 Machine usage (hours/night).
Figuras y tablas -
Analysis 2.1

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 1 Machine usage (hours/night).

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 2 N deemed adherent (≥ four hours/night).
Figuras y tablas -
Analysis 2.2

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 2 N deemed adherent (≥ four hours/night).

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 3 Epworth Sleepiness Scale scores.
Figuras y tablas -
Analysis 2.3

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 3 Epworth Sleepiness Scale scores.

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 4 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI).
Figuras y tablas -
Analysis 2.4

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 4 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI).

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 5 HAD Scale for Depression.
Figuras y tablas -
Analysis 2.5

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 5 HAD Scale for Depression.

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 6 Withdrawal.
Figuras y tablas -
Analysis 2.6

Comparison 2 Educational interventions + CPAP versus usual care + CPAP, Outcome 6 Withdrawal.

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 1 Machine usage (hours/night).
Figuras y tablas -
Analysis 3.1

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 1 Machine usage (hours/night).

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 2 Sensitivity analysis: excluding participants aware of machine usage monitoring.
Figuras y tablas -
Analysis 3.2

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 2 Sensitivity analysis: excluding participants aware of machine usage monitoring.

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 3 N deemed adherent (≥ four hours/night).
Figuras y tablas -
Analysis 3.3

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 3 N deemed adherent (≥ four hours/night).

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 4 Epworth Sleepiness Scale score.
Figuras y tablas -
Analysis 3.4

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 4 Epworth Sleepiness Scale score.

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 5 Quality of life: Functional Outcomes of Sleep Questionnaire.
Figuras y tablas -
Analysis 3.5

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 5 Quality of life: Functional Outcomes of Sleep Questionnaire.

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 6 Withdrawal.
Figuras y tablas -
Analysis 3.6

Comparison 3 Behavioural therapy + CPAP versus control + CPAP, Outcome 6 Withdrawal.

Summary of findings for the main comparison. Increased practical support and encouragement for adults with sleep apnoea

Increased practical support and encouragement for adults with sleep apnoea

Patient or population: adults with sleep apnoea
Intervention: increased practical support and encouragement and CPAP

Comparison: CPAP

Settings: community

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Increased practical support and encouragement

Machine usage
Hours per night
Follow‐up: median 12 weeks

Average CPAP machine usage ranged across control groups from
1.75 to 6.3 hours per night

Mean machine usage in the intervention groups was
0.82 hours higher
(0.36 to 1.27 higher)

803
(13 studies)

⊕⊕⊝⊝
low1,2

N deemed adherent (≥ four hours/night)
Follow‐up: median 12 weeks

59 per 100

75 per 100
(64 to 83)

OR 2.06
(1.22 to 3.47)

268
(4 studies)

⊕⊕⊝⊝
low1,3

Symptoms of sleepiness
Epworth Scale: zero to 24
Follow‐up: median 12 weeks

Average Epworth symptom scores in control groups ranged from

4.5 to 13

Mean symptoms of sleepiness in the intervention groups was
0.6 lower
(1.81 lower to 0.62 higher)

501
(8 studies)

⊕⊝⊝⊝
very low1,4,5

Quality of life
Functional Outcomes of Sleep Questionnaire

Mean quality of life in the intervention groups was
0.98 higher
(0.84 lower to 2.79 higher)

70
(2 studies)

⊕⊕⊝⊝
low1,6

Quality of life
Sleep Apnoea Quality of Life Index (SAQLI)

See comment

See comment

108
(1 study)

⊕⊕⊝⊝
low1,6

Single study estimate

Withdrawals
Follow‐up: median 12 weeks

17 per 100

11 per 100
(eight to 16)

OR 0.65
(0.44 to 0.97)

903
(12 studies)

⊕⊕⊕⊝
moderate1

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Risk of bias (‐1): In the absence of blinding across studies, the study effect estimates are at risk of performance bias.
2Inconsistency (‐1): Substantial variation was seen in the direction and magnitude of effect across studies (I2 = 66%). Removal of studies when average machine use in control groups was high yielded a more consistent, larger effect in favour of intervention.
3Imprecision (‐1): Low number of participants across studies was seen despite lower limit of the CI favouring intervention.
4Inconsistency (‐1): Substantial variation was seen in the direction and magnitude of effect across studies.
5Imprecision (‐1): Width of the confidence intervals does not exclude substantial improvement in deterioration of symptoms.
6Imprecision (‐1): Low number of participants and very wide confidence intervals were compatible with benefit and harm.

Figuras y tablas -
Summary of findings for the main comparison. Increased practical support and encouragement for adults with sleep apnoea
Summary of findings 2. Educational interventions for adults with sleep apnoea

Educational interventions for adults with sleep apnoea

Patient or population: adults with sleep apnoea
Intervention: educational interventions and CPAP

Comparison: CPAP

Settings: community

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Educational interventions

Machine usage
Hours per night
Follow‐up: 12 to 24 weeks

Average CPAP machine usage ranged across control groups from

2.6 to 5.7 hours per night

Mean machine usage in the intervention groups was
0.6 higher
(0.27 to 0.93 higher)

508
(7 studies)

⊕⊕⊕⊝
moderate1

N deemed adherent (≥4 hours/night)
Follow‐up: 12 to 24 weeks

57 per 100

71 per 100
(59 to 80)

OR 1.8
(1.09 to 2.95)

285
(3 studies)

⊕⊕⊝⊝
low1,2

Symptoms of sleepiness
Epworth Scale: 0 to 24
Follow‐up: median 12 weeks

Mean Epworth Sleepiness Scale scores across control groups ranged from

5.4 to 10.8

Mean Epworth Sleepiness Scale scores in the intervention groups was
1.17 lower
(2.07 to 0.26 lower)

336
(5 studies)

⊕⊕⊕⊝
moderate1

Quality of life: Sleep Apnoea Quality of Life Index (SAQLI)
Follow‐up: 4 weeks

See comment

See comment

Not estimable

89
(1 study)

⊕⊝⊝⊝
very low1,3

Single study estimate

Withdrawal
Follow‐up: 4 to 24 weeks

24 per 100

18 per 100
(13 to 24)

OR 0.67
(0.45 to 0.98)

683
(8 studies)

⊕⊕⊝⊝
low1,4

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Risk of bias (‐1): In the absence of blinding across studies, effect estimates may be biased because of performance bias.
2Imprecision (‐1): We downgraded because of the low number of participants in the analysis, in spite of the statistically significant increase in the number of participants deemed compliant.
3Imprecision (‐2): In view of the very low number of participants and the wide confidence intervals, we downgraded by two points.
4Inconsistency (‐1): The direction and magnitude of effect varied across studies.

Figuras y tablas -
Summary of findings 2. Educational interventions for adults with sleep apnoea
Summary of findings 3. Behavioural therapy for adults with sleep apnoea who are using CPAP

Behavioural therapy for adults with sleep apnoea who are using CPAP

Patient or population: adults with sleep apnoea
Intervention: behavioural therapy and CPAP

Comparison: CPAP

Settings: community

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Behavioural therapy

Machine usage
Hours per night

See comment

Average machine usage in the intervention groups was
1.44 higher
(0.43 to 2.45 higher)

584
(6 studies)

⊕⊕⊝⊝
low1,2

Data analysed as generic inverse variance

N deemed adherent (≥4 hours/night)
Follow‐up: four to 52 weeks

28 per 100

47 per 100
(36 to 58)

OR 2.23
(1.45 to 3.45)

358
(3 studies)

⊕⊝⊝⊝
very low1,3

Symptoms
Epworth scores

See comment

See comment

100
(1 study)

⊕⊕⊝⊝
low1,4

Single study estimate

Quality of life
Functional Outcomes of Sleep Questionnaire

See comment

See comment

100
(1 study)

⊕⊕⊝⊝
low1,4

Single study estimate

Withdrawal
Follow‐up: 4 to 52 weeks

23 per 100

20 per 100
(15 to 27)

OR 0.85
(0.57 to 1.25)

609
(5 studies)

⊕⊝⊝⊝
very low1,2,5

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Risk of bias (‐1): In the absence of blinding across studies, effect estimates may be biased because of performance bias.
2Inconsistency (‐1): Variation was seen in the magnitude and direction of effect across studies.
3Inconsistency (‐2): Very substantial variation was seen between direction and results of studies.
4Imprecision (‐1): Low number of participants contribute data to this outcome.
5Imprecision (‐1): Confidence intervals were compatible with reduction and increase in likelihood of study withdrawal.

Figuras y tablas -
Summary of findings 3. Behavioural therapy for adults with sleep apnoea who are using CPAP
Table 1. Number screened, entered and completed

Study

N Screened

Entered

Completed

% Screened

% Entered

Aloia 2001

NA

12

12

NA

100

Aloia 2012a, Aloia 2012b

339

227

149

44

66

Basoglu 2011

246

133

133

54

100

Chervin 1997

NA (75% of those approached agreed to participate)

40

33

NA

82.5

DeMolles 2004

NA

30

30

NA

100

Epstein 2000

NA

50

43

NA

86

Fox 2012

NA

75

54

NA

72

Hoy 1999

NA

80

75

NA

94

Hui 2000

NA

108

108

NA

100

Lewis 2006

74

72

55

74

76

Meurice 2007a, Meurice 2007b, Meurice 2007c, Meurice 2007d

133

112

91

68

81

Olsen 2012

132

100

73

55

73

Parthasarathy 2012

49

39

37

76

95

Richards 2007

109

100

79

72

79

Roecklein 2010

NA

30

28

NA

93

Schiefelbein 2005

NA

51

51

NA

100

Smith 2006

NA

19

19

NA

100

Smith 2009

NA

97

73

NA

75

Sparrow 2010

423

250

115

27

46

Stepnowsky 2007

91

45

40

44

88

Taylor 2006

160

132

114

71

86

Wang 2011a, Wang 2011b, Wang 2011c, Wang 2011d

NA

152

130

NA

86

Wiese 2005

NA

93

56

NA

60

Figuras y tablas -
Table 1. Number screened, entered and completed
Table 2. Study characteristics

Intervention group

Study

Intervention

Control

Study duration

(weeks)

Increased support and reinforcement components

Increased educational components

Behavioural therapy

Increased support and reinforcement

Chervin 1997

Weekly telephone calls to monitor progress and troubleshoot

Written information on OSA and CPAP

Usual care

Eight

DeMolles 2004

Computer‐based telecommunication system allowing for monitoring and reinforcing compliance

Education provided by the computer‐based telecommunication system

Usual care

Eight

Fox 2012

Telecomunication system allowing for daily monitoring of CPAP usage, timely detection and troubleshooting of problems

Usual care

12

Hoy 1999

2 additional titration nights in hospital, 4 additional visits at home by sleep nurses

Initial education at home with partner

Usual care

24

Hui 2000

2 additional early reviews by sleep physician and frequent telephone calls by sleep nurses

Videotape and additional education session

Usual care

12

Lewis 2006

1 additional early review by sleep physician and 1 early telephone interview with sleep nurse

Educational video

Usual care

52

Meurice 2007a

4 additional home visits in the first 3 months by sleep practitioner for problem solving

Written information and detailed explanation by the prescriber, additional education during home visits

Written information and detailed explanation by the prescriber + usual care

52

Meurice 2007b

4 additional home visits in the first 3 months by sleep practitioner for problem solving

Additional education during home visits

Usual care

52

Parthasarathy 2012

2 individual sessions and 8 telephone conversations with trained peer CPAP users providing support and sharing their positive experience with CPAP

Peers shared their knowledge on CPAP and OSA

Interventions delivered by peer contained elements of promoting self‐efficacy, risk perception, participant activation and motivation

Usual care

12

Schiefelbein 2005

Internet‐based application aimed at encouraging CPAP use and problem solving

Internet‐based application similar in format to intervention but directed activities in neutral health topics (vitamin intake)

16

Smith 2006

Home video‐link sessions delivered by nurse, who guided correct CPAP use and provided problem solving

Nurse provided education on CPAP and OSA

Home video‐link sessions similar in form to intervention but directed activities in neutral health topics (vitamin intake)

12

Smith 2009

Audiotaped music along with softly spoken directions on relaxation techniques and habit‐promoting instructions for using CPAP, user reminder placard

Handouts on benefits of CPAP adherence and health consequences of poor compliance

Audiotaped music along with spoken information about vitamins. Information packet similar in format to intervention, but content was on vitamins

24

Stepnowsky 2007

Wireless telemonitoring of compliance and treatment efficacy on daily basis and acting on the data via prespecified clinical pathways

Usual care

Eight

Taylor 2006

Internet‐based application aimed at monitoring self‐reported compliance, acting on the information in timely fashion

Usual care

Four

Wang 2011b

Progressive muscle relaxation

Usual care

12

Wang 2011c

Progressive muscle relaxation + 2 additional nights of CPAP titration

4hour group education session, written information, video CD

Two additional nights of CPAP titration + four‐hour group education session, written information, video CD + usual care

12

Increased education

Aloia 2012a

Two 45‐minute individual didactic sessions and one booster phone call by sleep nurse

Usual care

52

Basoglu 2011

10‐Minute educational video session on OSA and CPAP

Usual care

24

Epstein 2000

Educational and desensitisation course

Usual care

24

Meurice 2007c

4 additional home visits in the first 3 months by sleep practitioner for problem solving

Written information and detailed explanation by the prescriber, additional education during home visits

Four additional home visits in the first three months by sleep practitioner for problem solving and additional education + usual care

52

Meurice 2007d

Written information and detailed explanation by the prescriber

Usual care

52

Wang 2011a

2 additional nights of CPAP titration

Four‐hour group education session, written information, video CD

Usual care

12

Wang 2011d

Progressive muscle relaxation + 2 additional nights of CPAP titration

Four‐hour group education session, written information, video CD

Progressive muscle relaxation + usual care

12

Wiese 2005

15‐Minute educational video addressing misconception about OSA and barriers to effective CPAP treatment

Usual care

Four

Behavioural therapy

Aloia 2001

Elements of education on consequences of OSA and efficacy of CPAP

Two 45‐minute sessions of cognitive‐behavioural therapy interventions

Two 45‐minute sessions involving discussion on sleep architecture and sleep clinic

12

Aloia 2012b

Two 45‐minute sessions of Motivational Enhancement Therapy, one booster phone call

Usual care

52

Olsen 2012

45‐Minute individual education session

Three 30‐minute sessions of Motivational Interviewing Therapy

45‐Minute educational session + usual care

52

Richards 2007

Slide presentation and written information on OSA and CPAP

Two one‐hour group sessions of cognitive‐behavioural therapy

Usual care

Four

Roecklein 2010

Written personalised feedback report framed according to Motivational Enhancement Theory

Written information from the American Academy of Sleep Medicine

12

Sparrow 2010

Side effects management module incorporated in the automated telephone‐linked communication system

Information exchange on OSA and CPAP incorporated in the automated telephone‐linked communication system

Automated telephone‐linked communication system designed around the concept of Motivational Interviewing, which allowed one to assess and enhance CPAP compliance

General education on unrelated health topics via automated telephone‐linked communication system

52

Figuras y tablas -
Table 2. Study characteristics
Comparison 1. Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Machine usage (hours/night) Show forest plot

13

803

Mean Difference (IV, Random, 95% CI)

0.82 [0.36, 1.27]

2 Machine usage, sensitivity analysis: excluding participants aware of machine usage monitoring Show forest plot

6

378

Mean Difference (IV, Fixed, 95% CI)

1.07 [0.61, 1.52]

3 Machine usage, sensitivity analysis: adherence in control group < four hours/night Show forest plot

8

471

Mean Difference (IV, Fixed, 95% CI)

1.36 [0.96, 1.76]

4 N deemed adherent (≥ four hours/night) Show forest plot

4

268

Odds Ratio (M‐H, Fixed, 95% CI)

2.06 [1.22, 3.47]

5 Epworth Sleepiness Scale scores Show forest plot

8

501

Mean Difference (IV, Random, 95% CI)

‐0.60 [‐1.81, 0.62]

6 Quality of life: Functional Outcomes of Sleep Questionnaire Show forest plot

2

70

Mean Difference (IV, Fixed, 95% CI)

0.98 [‐0.84, 2.79]

7 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

8 Mood Show forest plot

3

312

Mean Difference (IV, Fixed, 95% CI)

‐0.94 [‐1.55, ‐0.33]

8.1 HAD Scale for Anxiety

1

80

Mean Difference (IV, Fixed, 95% CI)

‐1.10 [‐2.95, 0.75]

8.2 HAD Scale for Depression

3

232

Mean Difference (IV, Fixed, 95% CI)

‐0.93 [‐1.57, ‐0.28]

9 Withdrawals Show forest plot

12

903

Odds Ratio (M‐H, Fixed, 95% CI)

0.65 [0.44, 0.97]

10 AHI on treatment Show forest plot

2

115

Mean Difference (IV, Fixed, 95% CI)

‐0.07 [‐1.62, 1.48]

11 Maintenance of Wakefulness Test (MWT) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 1. Increased practical support and encouragement during follow‐up + CPAP versus usual care + CPAP
Comparison 2. Educational interventions + CPAP versus usual care + CPAP

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Machine usage (hours/night) Show forest plot

7

508

Mean Difference (IV, Fixed, 95% CI)

0.60 [0.27, 0.93]

2 N deemed adherent (≥ four hours/night) Show forest plot

3

285

Odds Ratio (M‐H, Fixed, 95% CI)

1.80 [1.09, 2.95]

3 Epworth Sleepiness Scale scores Show forest plot

5

336

Mean Difference (IV, Fixed, 95% CI)

‐1.17 [‐2.07, ‐0.26]

4 Quality of life: Sleep Apnoea Quality of Life Index (SAQLI) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 HAD Scale for Depression Show forest plot

2

152

Mean Difference (IV, Fixed, 95% CI)

‐0.52 [‐1.25, 0.22]

6 Withdrawal Show forest plot

8

683

Odds Ratio (M‐H, Fixed, 95% CI)

0.67 [0.45, 0.98]

Figuras y tablas -
Comparison 2. Educational interventions + CPAP versus usual care + CPAP
Comparison 3. Behavioural therapy + CPAP versus control + CPAP

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Machine usage (hours/night) Show forest plot

6

584

Mean Difference (Random, 95% CI)

1.44 [0.43, 2.45]

2 Sensitivity analysis: excluding participants aware of machine usage monitoring Show forest plot

5

Mean Difference (Fixed, 95% CI)

1.54 [0.99, 2.09]

3 N deemed adherent (≥ four hours/night) Show forest plot

3

358

Odds Ratio (M‐H, Fixed, 95% CI)

2.23 [1.45, 3.45]

4 Epworth Sleepiness Scale score Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Quality of life: Functional Outcomes of Sleep Questionnaire Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6 Withdrawal Show forest plot

5

609

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.57, 1.25]

Figuras y tablas -
Comparison 3. Behavioural therapy + CPAP versus control + CPAP