Respiratory rehabilitation to improve sleep in COPD

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

Stable COPD patients aged 50 and older who are eligible for pulmonary rehabilitation will have baseline clinical testing and overnight polysomnography to document sleep architecture. Participants will then complete a structured respiratory rehabilitation program combining supervised exercise training and patient education over several weeks. After the program, repeat polysomnography and clinical measures (daytime oxygenation, dyspnea scores, exercise capacity, and quality of life) will be obtained to compare sleep stages and sleep onset latency. The study focuses on objective changes in sleep architecture and related symptoms to see if rehabilitation can modify sleep disturbances in COPD.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu Rouen
  Rouen, France Recruiting
• Chu Amiens
  Amiens, France Not yet recruiting
• Gh Le Havre
  Le Havre, France Not yet recruiting
• Centre de Sante Adir
  Rouen, France Not yet recruiting

Study contacts

• Study coordinator: Marie-Anne Melone, MD, PhD
• Email: marieanne.melone@chu-rouen.fr
• Phone: (+33) 0232888265

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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.