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

NCT07047092 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Phase 3

Started

2026-06-03

Last updated

2026-06-09

Condition(s) studied

Chronic Obstructive Pulmonary Disease ExacerbationObstructive Sleep Apnea Exacerbation

Investigational drug(s) / intervention(s)

Non-invasive Ventilation (NIV)Continous Positive Airway Pressure (CPAP)

Non-invasive Ventilation (NIV): Patients will receive a dedicated training for the use of their NIV in the home setting. The training is the same provided in the usual care of patients established on NIV. They will choose a home care provider for the delivery of NIV as per standard care in France. A telemonitoring of adherence to NIV will be performed.

Continous Positive Airway Pressure (CPAP): Patients will receive a dedicated training the use of their CPAP in the home setting. The training is the same provided in the usual care of patients established on CPAP. They will choose a home care provider for the delivery of CPAP as per standard care in France. Follow-up of CPAP will be performed according to standard care in France and will therefore include a telemonitoring of adherence to CPAP.

Study 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

Sex

ALL

Min age

18 Years

Max age

84 Years

Healthy volunteers

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.

Primary outcome measure(s)

Demonstrate the superiority of home NIV versus home CPAP for the reduction of severe exacerbation of COPD or death. — 0-12 months from inclusion
Reduction of severe exacerbation of COPD or death, defined by the time to occurrence of (i) death from any cause or (ii) hospitalization in relation to severe exacerbation of COPD during a follow up of 12 months after randomization.

Trial sites (1)

Facility	City	Region	Status
Hospital Pitié-Salpêtrière - Sleep unit, R3S Departement	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07047092 on ClinicalTrials.gov ↗ ← All trials in France