Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT07047092
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT07047092
Study Brief:
Protocol Section:
NCT07047092