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Coronary Artery DiseasePhase 4RICCADSANCT00519597

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

A Phase 4 study testing ResMed S8 (Auto-CPAP) in people with Coronary Artery Disease and Obstructive Sleep Apnea, run by Skaraborg Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Any age
What is being tested?
ResMed S8 (Auto-CPAP)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
511 participants
Where
1 siteSweden
Study dates
Dec 2005to May 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Skaraborg Hospital

    Skövde, 54185

Other trials in Sweden

About this study

Official title: Randomized Intervention With CPAP in Coronary Artery Disease and Sleep Apnea - RICCADSA Trial

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.

Read the detailed description

Rationale: OSA is a common condition in CAD with a poor prognosis.Many of these subjects do not report daytime sleepiness, and therefore, are not considered for OSA treatment with CPAP. There is lack of evidence regarding the impact of CPAP on the long-term prognosis of CAD patients with OSA.

Objective: The RICCADSA trial is designed to address if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over a mean follow-up period of 3-years in CAD patients with OSA (Apnea-Hypopnea-Index [AHI]>=15 per h) without daytime sleepiness (Epworth Sleepiness Scale [ESS]<10). 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.

Patients and Methods: A sample of 511 CAD patients (122 non-sleepy OSA patients randomized to CPAP, 122 to non-CPAP; 155 sleepy OSA patients [ESS>=10] on CPAP, and 112 CAD patients without OSA [AHI <5 per h]) were included. The trial has 80% power to detect a risk reduction from an assumed composite end-point rate of 25% to 12% for the primary outcome at intention-to-treat basis.

Being tested
ResMed S8 (Auto-CPAP)
Keywords
Coronary Artery Disease, Sleep Apnea, CPAP, Revascularization, Mortality
Medical subject headings
Coronary Artery Disease, Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ResMed S8 (Auto-CPAP)Device

    AutoCPAP during sleep

Study groups in NCT00519597
Study groupRoleWhat they receive
IExperimentalAsymptomatic OSA (CPAP)
Receives: Device: ResMed S8 (Auto-CPAP)
IINo interventionAsymptomatic OSA (no CPAP)
IIIActive comparatorSymptomatic OSA (OSAS)
Receives: Device: ResMed S8 (Auto-CPAP)
IVNo interventionNon-OSA

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Three years

Secondary outcomes (1)

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

    Measured: Three months and one year, respectively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2007 (estimated)
  2. Study startDec 2005
  3. Primary completionMar 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00519597
Sponsor's protocol ID
VGSKAS-4731
Acronym
RICCADSA
Status last verified
Nov 2018
First submitted
20 Aug 2007
Last updated
15 Nov 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30324547

  • 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.

    PubMed 30130421

  • 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.

    PubMed 29243273

  • 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.

    PubMed 29217597

  • 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.

    PubMed 29029237

  • 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.

    PubMed 28408103

  • 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.

    PubMed 28296427

  • 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.

    PubMed 26914592

  • 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.

    PubMed 25547036

  • 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.

    PubMed 25325463

  • 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.

    PubMed 23952854

  • 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.

    PubMed 18663661

  • Thunstrom E, Glantz H, Pihtili A, Peker Y. Heart Failure With Preserved Ejection Fraction-Like Phenotype in Coronary Artery Disease and Obstructive Sleep Apnea: Insights From the RICCADSA Cohort. Clin Cardiol. 2026 Jul;49(7):e70402. doi: 10.1002/clc.70402.

    PubMed 42370761

  • Pihtili A, Glantz H, Thunstrom E, Peker Y. CPAP therapy may improve HFpEF-like features in coronary artery disease with obstructive sleep apnea: A randomized controlled trial. Sleep Med. 2026 Oct;146:109069. doi: 10.1016/j.sleep.2026.109069. Epub 2026 Jun 4.

    PubMed 42250441

  • 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.

    PubMed 40818776

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ResMed S8 (Auto-CPAP) in people with Coronary Artery Disease and Obstructive Sleep Apnea, run by Skaraborg Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The combined rate of cardiovascular mortality, stroke, myocardial infarction and the need for a new revascularization. (time frame: Three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00519597, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.

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RICCADSA Clinical Trial NCT00519597 | AzTrials