NCT07047092RecruitingPhase 3
Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 386 (estimated)
- First submitted
- 11 Jun 2025
- Start date
- 3 Jun 2026
- Primary completion date
- Oct 2029
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- COPD
- NCT number
- NCT07047092
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 386
- From 3 Jun 2026 to the primary completion date, Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant psychiatric disorder or dementia that would prevent adherence to study protocol
- Expected survival \<12 months due to any condition other than COPD.
Other
- Patient with NIV treatment
- Patients who decline any use of NIV or CPAP in the home setting
- Tobacco use \<10 pack-year
- Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- Pregnant or breastfeeding women
- Patient already involved in an interventional research protocol that would impact the outcome measured in the current protocol.
Who the study is looking for
- Age ≥ 18 and \< 85 years
- Patient with a diagnosis of COPD according to GOLD guidelines
- 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)
- Patient that has been weaned from acute NIV or invasive ventilation or high flow therapy
- 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.
- Affiliated to the National Health Patients affiliated or, beneficiary of social security, excluding AME (Aide Médicale d'État)
- Patient who has read and understood the information letter and signed the consent form
Age in the registry: 18 years to 84 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Pitié-Salpêtrière - Sleep unit, R3S Departement Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.