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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)

NCT05958563 · University Hospital, Angers
In plain English

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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
About this study
This study is an open labeled parallel group randomized controlled trial. The patients will be recruited within the pneumology consultations of the participating centers. Patients meeting the pre-inclusion criteria and having no exclusion criteria will be included in the study and will undergo a polysomnographic sleep recording (PSG). Patients with apnea hypopnea index (AHI) \<15 / hour and/or significant central apneas (≥5 central apneas per hour of sleep) during PSG will be excluded from the study. Patients with moderate to severe OSA (AHI ≥15 /h) and no significant central apneas will undergo baseline evaluation (ABG, 6 minute walking test, FEV1 and questionnaires) and then will be randomly assigned to receive 1 year of CPAP treatment (CPAP group) or no treatment of OSA (control group) according to a 1:1 allocation using a computer-generated randomization list stratified by site and OSA severity with permuted blocks of random sizes. Visit at 3,6 and 9 months: the following outcomes will be assessed: COPD exacerbations (number, date and severity), cardiovascular events, death and questionnaires. Visit at the end of the study (12 months): the following outcomes will be assessed: COPD exacerbations (number, date and severity), cardiovascular events, death, questionnaires, ABG, 6 minute walking test, FEV1. Statistical analysis for primary and secondary outcomes will be performed on an intention to treat basis. A per-protocol analysis will be also performed in patients with an average objective CPAP use of at least 4 hours per day. Pre-specified sensitivity analysis will be conducted according to age, gender, body-mass index, OSA and COPD severity.
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
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-01-09
Estimated completion: 2028-01-01
Last updated: 2025-04-13
Interventions
Device: continuous positive airway pressure treatment
Primary outcomes
  • annual rate of COPD exacerbations (12 months)
Sponsor
University Hospital, Angers · other_gov
With: Ministry of Health, France
Contacts & investigators
ContactWojciech Trzepizur, MD PhD · contact · wotrzepizur@chu-angers.fr · +33680575272
All locations (15)
Angers University HospitalRecruiting
Angers, France
Bordeaux University HospitalRecruiting
Bordeaux, France
Brest University HospitalRecruiting
Brest, France
AP-HP -Henri Mondor HsopitalRecruiting
Créteil, France
Dijon University HospitalRecruiting
Dijon, France
Grenoble University HospitalRecruiting
Grenoble, France
Le Mans HospitalRecruiting
Le Mans, France
Nancy University HospitalRecruiting
Nancy, France
AP-HP - Pitié Salpetrière HospitalRecruiting
Paris, France
Bichat Hospital - AP-HPRecruiting
Paris, France
Poitiers University HospitalRecruiting
Poitiers, France
Reims University HospitalRecruiting
Reims, France
Polyclinique Saint LaurentRecruiting
Rennes, France
Strasbourg University HospitalRecruiting
Strasbourg, France
Toulouse Universty HospitalRecruiting
Toulouse, France
Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS) · TrialPath