Non-invasive ventilation or CPAP for COPD with sleep apnea after a serious COPD flare

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with COPD who recently recovered from a severe COPD flare and have evidence of obstructive sleep apnea are screened and then randomized to receive NIV or CPAP to see if these therapies reduce readmissions and improve breathing. The trial includes in-hospital follow-up and visits at 3 and 6 months, with some remote data collection if needed. It is a Phase 3 interventional study conducted at a Paris sleep unit under a single lead sponsor. Patients must have completed acute ventilation and have documented OSA following weaning to be eligible.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Pitié-Salpêtrière - Sleep unit, R3S Departement
  Paris, France Recruiting

Study contacts

• Study coordinator: Maxime PATOUT, MD, PhD
• Email: maxime.patout@aphp.fr
• Phone: 01 42 16 77 09

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neutrophil-to-lymphocyte ratio in COPD flare-ups.

  This project will test whether a routine blood measure called the neutrophil-to-lymphocyte ratio can help predict severity, outcomes, and treatment response in adults hospitalized with COPD flare-ups.

  Recruiting Ain Shams University · Cairo, Abbasyea · NCT07125352

• Collecting data on COPD exacerbations in hospitalized patients

  This study is collecting health information and samples from 1,000 patients hospitalized for COPD flare-ups to help improve future treatments and understanding of the condition.

  Recruiting at 10 sites KU Leuven · Linz and 21 other locations · NCT05008081

• Diffusion MRI to map nerve lesions in obstetric brachial plexus palsy

  This study tests diffusion MRI and tractography to better understand nerve injuries in people with obstetric brachial plexus palsy.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07767708

• Long-term心理 and cognitive check after stem cell transplant for immune deficiencies

  This study tests the long-term neurocognitive and psychological functioning of 6–8 year-old children who had an allogeneic stem cell transplant for a primary immune deficiency, at least two years after the transplant.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07766304

• Benchmarking AI language models against tumor boards for oncology treatment decisions

  This project tests whether frontier AI language models can match the treatment recommendations of multidisciplinary tumor boards for common cancers using standardized synthetic cases.

  Recruiting Assistance Publique - Hôpitaux de Paris · Boulogne-Billancourt and 4 other locations · NCT07739121

• Gut microbes and autoinflammatory diseases: how they may be linked

  This study tests whether gut bacteria and their byproducts relate to digestive and inflammatory symptoms in people with autoinflammatory diseases.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07718555

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.