Effects of CPAP on COPD and Sleep Apnea Overlap Syndrome
Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS) SLEEPOVEA
This study is testing if using a CPAP machine can help people with both COPD and sleep apnea feel better and reduce health problems over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 15 sites (Angers and 14 other locations) |
| Trial ID | NCT05958563 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of continuous positive airway pressure (CPAP) treatment on patients suffering from both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA), known as Overlap Syndrome. Patients aged 40 and older with moderate to severe OSA will be randomly assigned to receive either CPAP treatment or no treatment for one year. The study will assess various outcomes, including the frequency and severity of COPD exacerbations, cardiovascular events, and overall mortality. Participants will undergo evaluations at baseline and follow-up visits at 3, 6, 9, and 12 months to monitor their health status and treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with a documented history of COPD and moderate to severe OSA.
Not a fit: Patients with mild OSA or significant central apneas, as well as those with severe daytime sleepiness, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of COPD exacerbations and improve overall health outcomes for patients with Overlap Syndrome.
How similar studies have performed: Previous observational studies have indicated that CPAP treatment can significantly improve outcomes in patients with COPD-OSA overlap, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 40 years of age or older * Grade of 2 or higher on the modified Medical Research Council scale (which ranges from 0 to 4, with higher grades indicating more severe dyspnea) * A post-bronchodilator forced expiratory volume in 1 second (FEV1) of less than 70% of the predicted value, and a postbronchodilator ratio of FEV1 to forced vital capacity (FVC) of less than 0.70. * Documented history of at least one moderate or severe COPD exacerbation during the previous year * Clinical suspicion of OSA (based on a STOP-bang questionnaire \>3), * Have a telephone or a tablet or accept to use one during the study, * Willing and able to comply with all study procedures, * Subjects covered by or having the rights to medical care assurance. * An apnea-hypopnea index \[AHI\], ≥15 per hour based on a full night polysomnography and no significant central apneas (\<5 central apneas per hour of sleep Exclusion Criteria: * Severe daytime sleepiness (Epworth sleepiness Scale \>14/24 and/or frequent sleepiness while driving or patient escaping a sleep-onset accident within the last 12 months), * Severe unstable cardiovascular disease (heart failure with FEVG≤45%, recurrent cardiac arrhythmia, instable coronary heart disease or stroke), * Patient on long-term oxygen therapy or non-invasive ventilation * Previously documented severe hypercapnia (PaCO2 ≥ 50mm Hg) * Previously diagnosed and treated OSA * Any rehabilitation program or any lung volume reduction procedure planned in the oncoming year * Pregnancy, breastfeeding * Bad understanding of the French language, * Other protected person according to articles L1121.7 and L1121.8 of the French Public Health Act
Where this trial is running
Angers and 14 other locations
- Angers University Hospital — Angers, France (Recruiting)
- Bordeaux University Hospital — Bordeaux, France (Recruiting)
- Brest University Hospital — Brest, France (Recruiting)
- AP-HP -Henri Mondor Hsopital — Créteil, France (Recruiting)
- Dijon University Hospital — Dijon, France (Recruiting)
- Grenoble University Hospital — Grenoble, France (Recruiting)
- Le Mans Hospital — Le Mans, France (Recruiting)
- Nancy University Hospital — Nancy, France (Recruiting)
- AP-HP - Pitié Salpetrière Hospital — Paris, France (Recruiting)
- Bichat Hospital - AP-HP — Paris, France (Recruiting)
- Poitiers University Hospital — Poitiers, France (Recruiting)
- Reims University Hospital — Reims, France (Recruiting)
- Polyclinique Saint Laurent — Rennes, France (Recruiting)
- Strasbourg University Hospital — Strasbourg, France (Recruiting)
- Toulouse Universty Hospital — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Wojciech Trzepizur, MD PhD
- Email: wotrzepizur@chu-angers.fr
- Phone: +33680575272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.