Continuous Positive Airway Pressure (CPAP) Treatment in Coronary Artery Disease and Sleep Apnea

NCT00519597 | Completed Phase 4 DMC

• 1 other identifier: VGSKAS-4731
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) worsens the prognosis in patients with coronary artery disease (CAD). Many of these subjects do not report daytime sleepiness, and therefore, are not considered for OSA treatment with continuous positive airway pressure (CPAP). There is lack of evidence regarding the impact of CPAP on the long-term prognosis of CAD patients with OSA. The Randomized Intervention with CPAP in CAD and OSA (RICCADSA) trial is designed to address if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over mean follow-up period of 3-years in CAD patients with OSA without daytime sleepiness.Secondary outcomes include cardiovascular biomarkers, cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and 1-year follow-up as well as polysomnographic findings and adherence to CPAP therapy.

Conditions

Coronary Artery Disease; Obstructive Sleep Apnea

Keywords

Coronary Artery Disease; Sleep Apnea; CPAP; Revascularization; Mortality

Outcome Measures

Primary Outcomes (1)

• The combined rate of cardiovascular mortality, stroke, myocardial infarction and the need for a new revascularization.

  Three years

Secondary Outcomes (1)

• Cardiovascular biomarkers, left ventricular function, maximal exercise capacity, quality of life, anxiety and depression state.

  Three months and one year, respectively.

Study Arms (4)

I

EXPERIMENTAL

Asymptomatic OSA (CPAP)

Device: ResMed S8 (Auto-CPAP)

II

NO INTERVENTION

Asymptomatic OSA (no CPAP)

III

ACTIVE COMPARATOR

Symptomatic OSA (OSAS)

Device: ResMed S8 (Auto-CPAP)

IV

NO INTERVENTION

Non-OSA

Interventions

ResMed S8 (Auto-CPAP) DEVICE

AutoCPAP during sleep

I; III

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with angiographically-verified CAD who have newly undergone PCI or CABG treatment
• Written, informed study consent
• OSA (AHI\>=15 per hour) or non-OSA (AHI\<5 per hour) diagnosis on the unattended sleep recording at home

You may not qualify if:

• Patients with already treated OSAS
• Patients presenting mainly central apneas (Cheynes-Stokes breathing)
• Patients with borderline OSA (AHI \<15 and \>=5 per hour) upon the unattended sleep recording at home

Sponsors & Collaborators

• Skaraborg Hospital: lead
• The Swedish Research Council: collaborator
• Swedish Heart Lung Foundation: collaborator
• Heart Foundation of Karnsjukhuset Sweden: collaborator
• ResMed Foundation: collaborator

Study Sites (1)

Skaraborg Hospital

Skövde, 54185, Sweden

Location

Related Publications (24)

• Baniak LM, Chasens ER, Luyster FS, Strollo PJ Jr, Thunstrom E, Peker Y. Obstructive sleep apnea and self-reported functional impairment in revascularized patients with coronary artery disease in the RICCADSA trial. Sleep Breath. 2018 Dec;22(4):1169-1177. doi: 10.1007/s11325-018-1733-4. Epub 2018 Oct 15.

  PMID: 30324547 RESULT

• Balcan B, Thunstrom E, Strollo PJ Jr, Peker Y. Continuous Positive Airway Pressure Treatment and Depression in Adults with Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea. A Secondary Analysis of the RICCADSA Trial. Ann Am Thorac Soc. 2019 Jan;16(1):62-70. doi: 10.1513/AnnalsATS.201803-174OC.

  PMID: 30130421 RESULT

• Luyster FS, Strollo PJ Jr, Thunstrom E, Peker Y. Long-term use of continuous positive airway pressure therapy in coronary artery disease patients with nonsleepy obstructive sleep apnea. Clin Cardiol. 2017 Dec;40(12):1297-1302. doi: 10.1002/clc.22827. Epub 2017 Dec 14.

  PMID: 29243273 RESULT

• Peker Y, Thunstrom E, Glantz H, Wegscheider K, Eulenburg C. Outcomes in coronary artery disease patients with sleepy obstructive sleep apnoea on CPAP. Eur Respir J. 2017 Dec 7;50(6):1700749. doi: 10.1183/13993003.00749-2017. Print 2017 Dec.

  PMID: 29217597 RESULT

• Thunstrom E, Glantz H, Yucel-Lindberg T, Lindberg K, Saygin M, Peker Y. CPAP Does Not Reduce Inflammatory Biomarkers in Patients With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea: A Randomized Controlled Trial. Sleep. 2017 Nov 1;40(11). doi: 10.1093/sleep/zsx157.

  PMID: 29029237 RESULT

• Glantz H, Johansson MC, Thunstrom E, Guron CW, Uzel H, Saygin M, Herlitz J, Peker Y. Effect of CPAP on diastolic function in coronary artery disease patients with nonsleepy obstructive sleep apnea: A randomized controlled trial. Int J Cardiol. 2017 Aug 15;241:12-18. doi: 10.1016/j.ijcard.2017.03.100. Epub 2017 Mar 25.

  PMID: 28408103 RESULT

• Peker Y, Wegscheider K, Eulenburg C. Reply: Effect of Continuous Positive Airway Pressure Therapy on Cardiovascular Outcomes: Risk Assessment. Am J Respir Crit Care Med. 2017 Sep 1;196(5):662-663. doi: 10.1164/rccm.201702-0420LE. No abstract available.

  PMID: 28296427 RESULT

• Peker Y, Glantz H, Eulenburg C, Wegscheider K, Herlitz J, Thunstrom E. Effect of Positive Airway Pressure on Cardiovascular Outcomes in Coronary Artery Disease Patients with Nonsleepy Obstructive Sleep Apnea. The RICCADSA Randomized Controlled Trial. Am J Respir Crit Care Med. 2016 Sep 1;194(5):613-20. doi: 10.1164/rccm.201601-0088OC.

  PMID: 26914592 RESULT

• Glantz H, Thunstrom E, Johansson MC, Wallentin Guron C, Uzel H, Ejdeback J, Nasic S, Peker Y. Obstructive sleep apnea is independently associated with worse diastolic function in coronary artery disease. Sleep Med. 2015 Jan;16(1):160-7. doi: 10.1016/j.sleep.2014.08.018. Epub 2014 Nov 18.

  PMID: 25547036 RESULT

• Thunstrom E, Glantz H, Fu M, Yucel-Lindberg T, Petzold M, Lindberg K, Peker Y. Increased inflammatory activity in nonobese patients with coronary artery disease and obstructive sleep apnea. Sleep. 2015 Mar 1;38(3):463-71. doi: 10.5665/sleep.4510.

  PMID: 25325463 RESULT

• Glantz H, Thunstrom E, Herlitz J, Cederin B, Nasic S, Ejdeback J, Peker Y. Occurrence and predictors of obstructive sleep apnea in a revascularized coronary artery disease cohort. Ann Am Thorac Soc. 2013 Aug;10(4):350-6. doi: 10.1513/AnnalsATS.201211-106OC.

  PMID: 23952854 RESULT

• Peker Y, Glantz H, Thunstrom E, Kallryd A, Herlitz J, Ejdeback J. Rationale and design of the Randomized Intervention with CPAP in Coronary Artery Disease and Sleep Apnoea--RICCADSA trial. Scand Cardiovasc J. 2009 Feb;43(1):24-31. doi: 10.1080/14017430802276106.

  PMID: 18663661 RESULT

• Peker Y, Celik Y, Zinchuk A, Sands SA, Redline S, Azarbarzin A. Association of Hypoxic Burden With Cardiovascular Events: A Risk Stratification Analysis of the Randomized Intervention With CPAP in Coronary Artery Disease and Sleep Apnea Cohort. Chest. 2025 Dec;168(6):1481-1493. doi: 10.1016/j.chest.2025.07.4081. Epub 2025 Aug 14.

  PMID: 40818776 DERIVED

• Balcan B, Celik Y, Strollo PJ, Peker Y. Characteristics of short REM sleepers and long-term CPAP use in the RICCADSA cohort. Sleep Med. 2025 Sep;133:106647. doi: 10.1016/j.sleep.2025.106647. Epub 2025 Jun 19.

  PMID: 40544785 DERIVED

• Sanchez-de-la-Torre M, Gracia-Lavedan E, Benitez ID, Sanchez-de-la-Torre A, Moncusi-Moix A, Torres G, Loffler K, Woodman R, Adams R, Labarca G, Dreyse J, Eulenburg C, Thunstrom E, Glantz H, Peker Y, Anderson C, McEvoy D, Barbe F. Adherence to CPAP Treatment and the Risk of Recurrent Cardiovascular Events: A Meta-Analysis. JAMA. 2023 Oct 3;330(13):1255-1265. doi: 10.1001/jama.2023.17465.

  PMID: 37787793 DERIVED

• Eulenburg C, Celik Y, Redline S, Thunstrom E, Glantz H, Strollo PJ Jr, Peker Y. Cardiovascular Outcomes in Adults with Coronary Artery Disease and Obstructive Sleep Apnea with versus without Excessive Daytime Sleepiness in the RICCADSA Cinical Trial. Ann Am Thorac Soc. 2023 Jul;20(7):1048-1056. doi: 10.1513/AnnalsATS.202208-676OC.

  PMID: 36800433 DERIVED

• Peker Y, Holtstrand-Hjalm H, Celik Y, Glantz H, Thunstrom E. Postoperative Atrial Fibrillation in Adults with Obstructive Sleep Apnea Undergoing Coronary Artery Bypass Grafting in the RICCADSA Cohort. J Clin Med. 2022 Apr 27;11(9):2459. doi: 10.3390/jcm11092459.

  PMID: 35566586 DERIVED

• Celik Y, Balcan B, Peker Y. CPAP Intervention as an Add-On Treatment to Lipid-Lowering Medication in Coronary Artery Disease Patients with Obstructive Sleep Apnea in the RICCADSA Trial. J Clin Med. 2022 Jan 5;11(1):273. doi: 10.3390/jcm11010273.

  PMID: 35012012 DERIVED

• Reynor A, McArdle N, Shenoy B, Dhaliwal SS, Rea SC, Walsh J, Eastwood PR, Maddison K, Hillman DR, Ling I, Keenan BT, Maislin G, Magalang U, Pack AI, Mazzotti DR, Lee CH, Singh B. Continuous positive airway pressure and adverse cardiovascular events in obstructive sleep apnea: are participants of randomized trials representative of sleep clinic patients? Sleep. 2022 Apr 11;45(4):zsab264. doi: 10.1093/sleep/zsab264.

  PMID: 34739082 DERIVED

• Behboudi A, Thelander T, Yazici D, Celik Y, Yucel-Lindberg T, Thunstrom E, Peker Y. Association of TNF-alpha (-308G/A) Gene Polymorphism with Circulating TNF-alpha Levels and Excessive Daytime Sleepiness in Adults with Coronary Artery Disease and Concomitant Obstructive Sleep Apnea. J Clin Med. 2021 Jul 31;10(15):3413. doi: 10.3390/jcm10153413.

  PMID: 34362196 DERIVED

• Zinchuk AV, Chu JH, Liang J, Celik Y, Op de Beeck S, Redeker NS, Wellman A, Yaggi HK, Peker Y, Sands SA. Physiological Traits and Adherence to Sleep Apnea Therapy in Individuals with Coronary Artery Disease. Am J Respir Crit Care Med. 2021 Sep 15;204(6):703-712. doi: 10.1164/rccm.202101-0055OC.

  PMID: 34156917 DERIVED

• Celik Y, Thunstrom E, Strollo PJ Jr, Peker Y. Continuous positive airway pressure treatment and anxiety in adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial. Sleep Med. 2021 Jan;77:96-103. doi: 10.1016/j.sleep.2020.11.034. Epub 2020 Dec 4.

  PMID: 33341644 DERIVED

• Peker Y, Thunstrom E, Glantz H, Eulenburg C. Effect of Obstructive Sleep Apnea and CPAP Treatment on Cardiovascular Outcomes in Acute Coronary Syndrome in the RICCADSA Trial. J Clin Med. 2020 Dec 15;9(12):4051. doi: 10.3390/jcm9124051.

  PMID: 33333899 DERIVED

• Wallstrom S, Balcan B, Thunstrom E, Wolf A, Peker Y. CPAP and Health-Related Quality of Life in Adults With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea in the RICCADSA Trial. J Clin Sleep Med. 2019 Sep 15;15(9):1311-1320. doi: 10.5664/jcsm.7926.

  PMID: 31538602 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Yüksel Peker, Ass. Prof.

  Göteborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: August 20, 2007
• First Posted: August 22, 2007
• Study Start: December 1, 2005
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

SE (1)