NCT07047092 Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 386 participants in total. It began in 2026-06-03 with a primary completion date of 2029-10.

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a major public health problem with 212.3 million prevalent cases of COPD worldwide and 3.3 million deaths related to COPD in 2019. Obstructive sleep apnoea (OSA) is the most common sleep disordered breathing. It is estimated that almost 1 billion adults have OSA worldwide. Given the increasing prevalence of obesity, co-morbid OSA is frequently seen in patients with COPD. Co-morbid OSA has been shown to increase mortality, to reduce quality of life and to favour acute exacerbation of COPD. For those admitted for a life-threatening exacerbation of COPD requiring an intensive care admission for acute hypercapnic failure, they are more likely to get readmitted. For those admitted for an acute exacerbation in any ward, they are more likely to be re-admitted for another exacerbation within 180-days if their OSA is not treated. Unfortunately, data regarding the best management of OSA in patients with co-morbid COPD are lacking as they were often excluded from clinical trials involving patients with COPD. Therefore, CPAP or NIV are administered without scientific evidence establishing which treatment is the most appropriate.

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.

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