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Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)
Sponsor: University Hospital, Angers
Summary
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".
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) SLEEPOVEA
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-01-09
Completion Date
2028-01-01
Last Updated
2025-04-13
Healthy Volunteers
No
Interventions
continuous positive airway pressure treatment
CPAP treatment for one year
Locations (15)
Angers University Hospital
Angers, France
Bordeaux University Hospital
Bordeaux, France
Brest University Hospital
Brest, France
AP-HP -Henri Mondor Hsopital
Créteil, France
Dijon University Hospital
Dijon, France
Grenoble University Hospital
Grenoble, France
Le Mans Hospital
Le Mans, France
Nancy University Hospital
Nancy, France
AP-HP - Pitié Salpetrière Hospital
Paris, France
Bichat Hospital - AP-HP
Paris, France
Poitiers University Hospital
Poitiers, France
Reims University Hospital
Reims, France
Polyclinique Saint Laurent
Rennes, France
Strasbourg University Hospital
Strasbourg, France
Toulouse Universty Hospital
Toulouse, France