Actively Recruiting
Impact of Continuous Positive Airway Pressure on Acute Exacerbations in Patients With COPD-OSA Overlap Syndrome (CO-OS) SLEEPOVEA
Led by University Hospital, Angers · Updated on 2025-04-13
500
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Angers
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the combined impact of Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA), known as Overlap Syndrome (CO-OS), which affects a significant portion of adults. Observational studies suggest that untreated OSA in CO-OS patients may worsen outcomes, including higher mortality and more frequent COPD exacerbations. However, controlled studies are needed to confirm whether treatment with continuous positive airway pressure (CPAP) improves these outcomes. This open-label randomized controlled trial will enroll patients with both COPD and moderate to severe OSA, confirmed by sleep testing, who will be randomly assigned to one year of CPAP treatment or no OSA treatment. Participants with mild or central apnea will be excluded. The trial will include follow-up visits at 3, 6, 9, and 12 months to monitor COPD exacerbations, cardiovascular events, mortality, and quality of life. Additional lung function and exercise tests will be performed at the start and end of the study. During the study, participants will undergo assessments including polysomnography, arterial blood gases, lung function tests, 6-minute walk tests, and questionnaires about symptoms and sleep quality. Researchers will track the number and severity of COPD exacerbations and cardiovascular events over one year. The study will analyze results for all participants and specifically for those who use CPAP for at least 4 hours per day. Safety and effectiveness will be monitored throughout the trial period.
CONDITIONS
Brief Title
Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 40 years of age or older
- Grade 2 or higher on the modified Medical Research Council scale for breathlessness
- Post-bronchodilator FEV1 less than 70% of predicted and FEV1/FVC ratio less than 0.70
- History of at least one moderate or severe COPD exacerbation in the previous year
- Clinical suspicion of obstructive sleep apnea based on STOP-bang questionnaire score greater than 3
- Have access to or agree to use a telephone or tablet during the study
- Willing and able to comply with all study procedures
- Covered by or have rights to medical care coverage
- Apnea-hypopnea index (AHI) of 15 or more per hour on polysomnography with less than 5 central apneas per hour of sleep
You will not qualify if you...
- Severe daytime sleepiness (Epworth Sleepiness Scale score over 14/24 or frequent sleepiness while driving or recent sleep-onset accident)
- Severe unstable cardiovascular disease including heart failure with ejection fraction 45% or less, recurrent arrhythmia, unstable coronary disease, or stroke
- Current use of long-term oxygen therapy or non-invasive ventilation
- Previously documented severe hypercapnia (PaCO2 50 mm Hg or higher)
- Previously diagnosed and treated obstructive sleep apnea
- Planned rehabilitation program or lung volume reduction procedure within the next year
- Pregnancy or breastfeeding
- Poor understanding of the French language
- Protected persons under French Public Health Act articles L1121.7 and L1121.8
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for polysomnographic sleep recording (PSG) and eligibility assessment
Duration - Up to 1 week
Participants with confirmed moderate to severe obstructive sleep apnea and no significant central apneas undergo baseline assessments and are randomly assigned to the treatment or control group.
1 baseline visit (in-person) for arterial blood gases, 6 minute walking test, lung function tests, and questionnaires
Duration - 1 year
Participants in the CPAP group receive continuous positive airway pressure treatment for one year, while control group participants do not receive CPAP treatment.
Visits at 3, 6, and 9 months to assess COPD exacerbations, cardiovascular events, death, and questionnaires
Duration - 1 day
At 12 months, participants complete final assessments including COPD exacerbations, cardiovascular events, death, questionnaires, arterial blood gases, 6 minute walking test, and lung function tests.
1 final visit (in-person)
Trial Site Locations
Total: 15 locations
1
Angers University Hospital
Angers, France
Actively Recruiting
2
Bordeaux University Hospital
Bordeaux, France
Actively Recruiting
3
Brest University Hospital
Brest, France
Actively Recruiting
4
AP-HP -Henri Mondor Hsopital
Créteil, France
Actively Recruiting
5
Dijon University Hospital
Dijon, France
Actively Recruiting
6
Grenoble University Hospital
Grenoble, France
Actively Recruiting
7
Le Mans Hospital
Le Mans, France
Actively Recruiting
8
Nancy University Hospital
Nancy, France
Actively Recruiting
9
AP-HP - Pitié Salpetrière Hospital
Paris, France
Actively Recruiting
10
Bichat Hospital - AP-HP
Paris, France
Actively Recruiting
11
Poitiers University Hospital
Poitiers, France
Actively Recruiting
12
Reims University Hospital
Reims, France
Actively Recruiting
13
Polyclinique Saint Laurent
Rennes, France
Actively Recruiting
14
Strasbourg University Hospital
Strasbourg, France
Actively Recruiting
15
Toulouse Universty Hospital
Toulouse, France
Actively Recruiting
Research Team
W
Wojciech Trzepizur, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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