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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)

RecruitingNAAges 40 Years - anyAllUniversity Hospital, Angers
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In plain words

What the trial is, and whether it could suit you

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 patie

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📋 Eligibility rules (as published)
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
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What it tests

  • continuous positive airway pressure treatment
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Where

15 sites
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

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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