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Taking people in FrancePhase 3

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.

Key facts

Who runs it
Assistance Publique - Hôpitaux de Paris
Where
Paris, FranceSee the site
Trial code
Registry title
Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
Status
Recruiting
Phase
Phase 3
People taking part
386 people, planned
Started
3 Jun 2026
Expected to end
Oct 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Non-invasive Ventilation (NIV)
  • Continous Positive Airway Pressure (CPAP)
Record updated
9 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with COPD and sleep apnoea who were in hospital with a COPD flare-up that needed breathing support and who have since come off that support.

Age
18 to 84 years (at least 18 and under 85).
Sex
All sexes can join.
Disease stage
COPD diagnosed by GOLD guidelines, admitted for an acute flare-up needing acute NIV, invasive ventilation or high-flow therapy (pH <7.35 with PaCO2 >45mmHg/6kPa), now weaned off. A sleep study 2 to 30 days after weaning must show an obstructive apnea-hypopnea index >=15/h.
Earlier treatment
Must have been weaned from acute NIV, invasive ventilation or high-flow therapy. People already on NIV treatment cannot join.
Biomarker or test result
Obstructive apnea-hypopnea index >=15/h on an overnight polygraphy or polysomnography.

Main reasons for not taking part

  • Already on NIV treatment
  • Refuses any use of NIV or CPAP at home
  • Significant psychiatric disorder or dementia that would stop them following the study
  • Tobacco use under 10 pack-years
  • Expected survival under 12 months due to a condition other than COPD

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in France

  • Hospital Pitié-Salpêtrière - Sleep unit, R3S DepartementParis, FranceContact: Maxime PATOUT, MD PhDTaking people

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

  • Non-invasive Ventilation (NIV)Treatment being tested

    Patients randomised to the intervention arm will be established on NIV before discharge to home.

  • Continuous Positive Airway Pressure (CPAP)Existing treatment, for comparison

    Patients randomised to the control arm will be established on CPAP before discharge to home.

    Treatment: Continous Positive Airway Pressure (CPAP)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
Plain-language title
Comparing two breathing machines for COPD patients who also have sleep apneaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07047092, who can take part
Record updated
9 June 2026