NCT06677268Recruiting
Respiratory Rehabilitation and Sleep Quality in COPD Patients
Benefit of Respiratory Rehabilitation on Objective Sleep Quality in Patients With Stable COPD
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
COPD affects 5 to 8% of the population in France. The disease consists of inflammation of the large and small airways causing permanent obstruction of the airways and symptoms such as dyspnea, cough and sputum that worsens over time. Among all COPD patients, 40% complain of sleep disorders. Polysomnography data showed a prolongation of sleep onset latency and a decrease in deep sleep, correlated with the severity of daytime hypoxemia. Conversely, poor sleep quality leads to an increase in dyspnea, altered quality of life and increased occurrence of COPD exacerbations. Respiratory rehabilitation has demonstrated significant benefits on exercise capacity, dyspnea, COPD exacerbations and quality of life. To the investigators' knowledge, a few studies have investigated the relationship between physical activity and sleep quality using polysomnography in this population. Thus, the aim of the study is to evaluate the benefits of respiratory rehabilitation on sleep architecture in patients with COPD. Investigators' hypothesis is that a respiratory rehabilitation program would improve the quality of sleep measured by polysomnography. Therefore, patient with COPD and no exacerbation in the previous year will be randomly assigned to the interventional group who perform the rehabilitation program or to the control group who will not perform the program. The primary endpoint is the sleep quality estimated by total sleep time as measured by the mean of 2 independent polysomnography readings, at baseline and after the RR program in the interventional group and after 2 months of usual care in the control group.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 15 Oct 2024
- Start date
- 19 Feb 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- University Hospital, Rouen
- Diseases
- COPD
- NCT number
- NCT06677268
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 19 Feb 2025 to the primary completion date, Feb 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously documented OSA (AHI \> 10/h)
- Patient on systemic corticosteroid therapy
- Patient on centrally acting therapy (benzodiazepine or opiate)
Other illness
- Patient with other associated chronic respiratory insufficiency
- Patient with active cancer
- Patient with neuromuscular disease
- Psychiatric, cognitive or linguistic disorders with inability to understand to follow the protocol
Other
- BMI≥ 30 kg/m2
- Patient with a CPAP or NIV
- Patient with an occurrence of severe COPD exacerbation
- Patient with an osteoarticular disability or traumatic or neurological sequelae preventing participation in the respiratory rehabilitation program
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Not yet recruiting |
| GH Le Havre Coordinator of this site? Confirm its status | Le Havre | France | Not yet recruiting |
| Centre de Sante Adir Coordinator of this site? Confirm its status | Rouen | France | Not yet recruiting |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.