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

Launched by UNIVERSITY HOSPITAL, ANGERS · Jul 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how continuous positive airway pressure (CPAP) therapy might help patients who have both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA), a condition known as Overlap Syndrome (CO-OS). Researchers want to find out if treating OSA with CPAP can reduce the number of severe COPD flare-ups and improve overall health in these patients. Previous studies suggest that untreated OSA can lead to worse outcomes for individuals with COPD, but there hasn't been a controlled study to confirm this.

To participate in the trial, individuals must be 40 years or older, have significant breathing difficulties, and a history of at least one moderate or severe COPD flare-up in the past year. They also need to have signs of OSA, confirmed by a sleep study. Participants will need to use a phone or tablet during the study and be willing to follow the procedures. Throughout the trial, participants can expect regular check-ins and support related to their treatment. This research is important because it could help improve care for people with both COPD and OSA, which currently lacks clear treatment guidelines.

Gender

ALL

Eligibility criteria

• 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