Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 1, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the best way to help people who have both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) after they have been hospitalized for a serious breathing problem caused by COPD. COPD is a lung disease that makes it hard to breathe, and OSA is a condition where breathing stops and starts during sleep. Many people with COPD also have OSA, and this combination can make their health worse and lead to more hospital visits. Right now, doctors often use machines called CPAP or non-invasive ventilation (NIV) to help these patients breathe, but there isn’t enough research to know which treatment works best for people dealing with both conditions.

Adults aged 18 to 85 who have COPD and have recently been treated in the hospital for a severe breathing problem may be eligible to join the trial. To participate, patients must have confirmed OSA from a sleep test done shortly after their hospital stay. Those who are already on home breathing machines or who cannot use these devices won’t be able to join. Participants will receive either CPAP or NIV treatment after leaving the hospital, and the study will help doctors understand which option is better at preventing future breathing problems and hospital visits. If you or a family member fits these criteria and is interested, this trial could offer important new information to help improve care for people with COPD and OSA.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 and \< 85 years
• • 2. Patient with a diagnosis of COPD according to GOLD guidelines
• • 3. Patient admitted for an acute exacerbation of COPD requiring acute NIV or invasive ventilation or high-flow therapy (pH \<7.35 with PaCO2 \>45mmHg/6kPa)
• • 4. Patient that has been weaned from acute NIV or invasive ventilation or high flow therapy
• • 5. Patient with an overnight polygraphy or polysomnography performed 2 to 30 days following weaning from acute NIV or invasive ventilation showing an obstructive apneahypopnea index \>=15/h. For patients already diagnosed with OSA, results from their prior sleep study will be retrieved. If not accessible, overnight polygraphy or polysomnography will be repeated.
• • 6. Affiliated to the National Health Patients affiliated or, beneficiary of social security, excluding AME (Aide Médicale d'État)
• • 7. Patient who has read and understood the information letter and signed the consent form
• Exclusion Criteria:
• • 1. Patient with NIV treatment
• • 2. Patients who decline any use of NIV or CPAP in the home setting
• • 3. Significant psychiatric disorder or dementia that would prevent adherence to study protocol
• • 4. Tobacco use \<10 pack-year
• • 5. Expected survival \<12 months due to any condition other than COPD.
• • 6. Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
• • 7. Pregnant or breastfeeding women
• • 8. Patient already involved in an interventional research protocol that would impact the outcome measured in the current protocol.