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 @ 5:51 PM
Ignite Modification Date:
2025-12-24 @ 5:51 PM
NCT ID:
NCT06677268
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ age 50
* COPD defined according to the GOLD 2022 criteria, clinically stable (without exacerbation for at least 4 weeks), with indication for respiratory rehabilitation
* Absence of respiratory rehabilitation in the past 12 months
* Patient affiliated to the social security system
* For women of childbearing potential who have been on effective contraception (estrogen-progestogen or intrauterine device or tubal ligation) for 1 month.
* For postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
* Patient who has read and understood the information letter and signed the consent form
Exclusion Criteria:
* BMI≥ 30 kg/m2
* Previously documented OSA (AHI \> 10/h)
* Patient with a CPAP or NIV
* Patient on systemic corticosteroid therapy
* Patient on centrally acting therapy (benzodiazepine or opiate)
* Patient with an occurrence of severe COPD exacerbation
* Patient with other associated chronic respiratory insufficiency
* Patient with active cancer
* Patient with neuromuscular disease
* Patient with an osteoarticular disability or traumatic or neurological sequelae preventing participation in the respiratory rehabilitation program
* Psychiatric, cognitive or linguistic disorders with inability to understand to follow the protocol
* Patient with a contraindication to respiratory rehabilitation or any pathology preventing physical rehabilitation
* Patient with a cardiovascular contraindication to respiratory rehabilitation
* Person deprived of liberty by an administrative or judicial decision or person placed under judicial safeguard, guardianship or curatorship
* Person subject to a legal protection measure
* Pregnant or parturient or breastfeeding woman
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06677268
Study Brief:
Protocol Section:
NCT06677268