Effects of CPAP on COPD and Sleep Apnea Overlap Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of continuous positive airway pressure (CPAP) treatment on patients suffering from both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA), known as Overlap Syndrome. Patients aged 40 and older with moderate to severe OSA will be randomly assigned to receive either CPAP treatment or no treatment for one year. The study will assess various outcomes, including the frequency and severity of COPD exacerbations, cardiovascular events, and overall mortality. Participants will undergo evaluations at baseline and follow-up visits at 3, 6, 9, and 12 months to monitor their health status and treatment effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Angers University Hospital
  Angers, France Recruiting
• Bordeaux University Hospital
  Bordeaux, France Recruiting
• Brest University Hospital
  Brest, France Recruiting
• AP-HP -Henri Mondor Hsopital
  Créteil, France Recruiting
• Dijon University Hospital
  Dijon, France Recruiting
• Grenoble University Hospital
  Grenoble, France Recruiting

Study contacts

• Study coordinator: Wojciech Trzepizur, MD PhD
• Email: wotrzepizur@chu-angers.fr
• Phone: +33680575272

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using a sleep medication to help people with obstructive sleep apnea tolerate CPAP

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• High-intensity resistance training after a COPD exacerbation

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• Neurostimulation treatment for sleep-disordered breathing

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.