RecruitingNot ApplicableNCT05958563

Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)

Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS) SLEEPOVEA


Sponsor

University Hospital, Angers

Enrollment

500 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

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".


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether using a CPAP machine (a device worn during sleep that keeps the airway open) can reduce the number of severe flare-ups (exacerbations) in people who have both COPD (chronic obstructive pulmonary disease, a lung condition) and sleep apnea (breathing pauses during sleep). **You may be eligible if...** - You are 40 or older with moderate-to-severe COPD and at least one bad flare-up in the past year - You have symptoms of sleep apnea (STOP-Bang score above 3) confirmed by a sleep study (AHI of 15 or more per hour) - You experience significant breathlessness - You have a phone, tablet, or are willing to use one **You may NOT be eligible if...** - You have severe daytime sleepiness or have had a car accident due to falling asleep - You already use CPAP, long-term oxygen, or non-invasive ventilation - You have severe unstable heart disease or a history of severe high carbon dioxide levels - You are pregnant or breastfeeding - You do not speak French (this study is conducted in France) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEcontinuous 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

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NCT05958563


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