Respiratory rehabilitation to improve sleep in COPD
Benefit of Respiratory Rehabilitation on Objective Sleep Quality in Patients With Stable COPD
This trial will test whether a respiratory rehabilitation program can improve sleep quality measured by overnight polysomnography in people aged 50 and older with stable COPD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 4 sites (Amiens and 3 other locations) |
| Trial ID | NCT06677268 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 or older with stable COPD (per GOLD criteria) who have not had respiratory rehabilitation in the past 12 months and who do not have obesity (BMI < 30) or previously diagnosed obstructive sleep apnea.
Not a fit: Patients with BMI ≥ 30, known OSA (AHI > 10/h), those using CPAP or NIV, on systemic corticosteroids or sedating central nervous system drugs, or with recent severe exacerbations are unlikely to be eligible or may not benefit.
Why it matters
Potential benefit: If successful, the program could improve sleep quality and deep sleep, reduce daytime breathlessness, and lower the risk of COPD exacerbations.
How similar studies have performed: Respiratory rehabilitation has established benefits for exercise capacity, dyspnea, and quality of life in COPD, but few studies have used polysomnography to demonstrate clear improvements in objective sleep architecture, making this application partly novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens and 3 other locations
- 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)
- Chu Rouen — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Marie-Anne Melone, MD, PhD
- Email: marieanne.melone@chu-rouen.fr
- Phone: (+33) 0232888265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.