Which home breathing machine best prevents COPD Flare-Ups? major trial launches
NCT ID NCT07047092
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a non-invasive ventilator (NIV) or a CPAP machine is better at preventing severe COPD flare-ups and death in people who also have sleep apnea. About 386 adults who recently survived a life-threatening breathing crisis will use one of the two machines at home for a year. The goal is to see which device reduces hospital readmissions and improves breathing control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Non-invasive ventilation (NIV) or continuous positive airway pressure (CPAP) devices
- What this could lead to
- If this trial succeeds, it could show which breathing machine (NIV or CPAP) works best at home to prevent future severe COPD flare-ups and hospital stays in people who also have sleep apnea.
- What could go wrong
- This is a phase 3 trial, but it only compares two existing devices, not a new drug. The benefit may be modest, and results may not apply to all patients with COPD and sleep apnea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 386 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 84 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Pitié-Salpêtrière - Sleep unit, R3S Departement
RECRUITINGParis, 75013, France
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