Comparing two breathing machines for COPD patients who also have sleep apnea
Compares two breathing devices in adults with COPD and sleep apnea after hospital admission.
Plain-language title generated from the registry record
Registry title: Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
Key facts
- Where
- Paris, FranceSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 84 years old?
Source: NCT07047092, who can take part
Where in France
- Hospital Pitié-Salpêtrière - Sleep unit, R3S DepartementParis, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT07047092
- Record updated
- 9 June 2026
- Original description
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.Read full original descriptionShow less
Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
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.
Inclusion: 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.
Exclusion: Significant psychiatric disorder or dementia that would prevent adherence to study protocol; Expected survival <12 months due to any condition other than COPD; 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.