Actively Recruiting
Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)
Led by University Hospital, Angers · Updated on 2025-04-13
500
Participants Needed
15
Research Sites
207 weeks
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
Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) are both frequent respiratory diseases with estimated prevalences between 8 and 15% of the adult population. Because of those high prevalences those two entities are often associated in same patients (1 to 4% of the general population). This association is then referred to as Overlap Syndrome (CO-OS). Data from observational studies suggest that this association may have an additive or even synergistic negative impact on patient's prognosis. Indeed, in a cohort of patients diagnosed as having a CO-OS, patients who did not receive specific treatment for OSA had a 76% increased risk of death compared to patients treated with continuous positive airway pressure (CPAP) and a 2-fold increased risk of acute COPD exacerbation. In another cohort of patients with both OSA and severe oxygen treated COPD, untreated patients for OSA had a 5-fold increased risk of death compared to patients treated with CPAP. There are strong signals from observational studies in support of a beneficial impact of CPAP therapy on respiratory outcomes in patients with CO-OS. However, those findings are not supported by any controlled study. It is difficult to directly transpose the observational data to current clinical practice in the context of the recent studies on the impact of CPAP on OSA prognosis. Indeed, data from similar observational OSA cohorts have reported a major impact of CPAP on the overall survival and cardiovascular outcomes in patients with OSA. Ten years later, this impact has not been confirmed by several randomized studies. To date, there is no consensus on a systematic screening and, if present, management of OSA in patients with COPD. The need for specific research on that field was emphasized in 2018 in an official American Thoracic Society Research Statement which recommends "randomized trials that compare clinical outcomes among patients with Overlap Syndrome whose OSA is treated to clinical outcomes among patients with Overlap Syndrome whose OSA is untreated".
CONDITIONS
Official 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 of 2 or higher on the modified Medical Research Council scale
- Post-bronchodilator FEV1 less than 70% 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 OSA based on a STOP-bang questionnaire score greater than 3
- Have or willing 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 assurance
- Apnea-hypopnea index of 15 or more per hour with less than 5 central apneas per hour on polysomnography
You will not qualify if you...
- Severe daytime sleepiness (Epworth sleepiness scale >14/24 or frequent sleepiness while driving or history of sleep-onset accident in last 12 months)
- Severe unstable cardiovascular disease (heart failure with left ventricular ejection fraction ≤45%, recurrent arrhythmia, unstable coronary heart disease or stroke)
- On long-term oxygen therapy or non-invasive ventilation
- Previously documented severe hypercapnia (PaCO2 ≥50 mm Hg)
- 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 French language
- Protected person according to articles L1121.7 and L1121.8 of the French Public Health Act
AI-Screening
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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
CONTACT
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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