Respiratory Rehabilitation and Sleep Quality in COPD Patients (REARSOM/BPCO)

February 16, 2026 updated by: University Hospital, Rouen

Benefit of Respiratory Rehabilitation on Objective Sleep Quality in Patients With Stable COPD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80054
      • Le Havre, France, 76083
      • Rouen, France, 76031
      • Rouen, France, 76000
        • Not yet recruiting
        • Centre de Sante Adir
        • Contact:
        • Sub-Investigator:
          • Adriana Portmann, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Respiratory Rehabilitation
Patient in this arm will perform a 2-months respiratory rehabilitation program
Procedure: Rehabilitation
Patients will undergo a respiratory rehabilitation program (24 exercise sessions of 90 minutes each, three times a week for 8 weeks and up to 9 therapeutic education workshops of 1 hour)
No Intervention: Usual care
Patient in the control group (usual care) will have standard care without respiratory rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sleep time (TST)
Time Frame: Baseline and end of respiratory rehabilitation (2 months)
measured by the average of the 2 independent polysomnography scorings
Baseline and end of respiratory rehabilitation (2 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep onset latency
Time Frame: From enrollment to the end of the follow-up at 11 weeks
Sleep onset latency (SOL) measured by the average of the 2 independent polysomnography readings
From enrollment to the end of the follow-up at 11 weeks
Pittsburgh sleep quality index (PSQI)
Time Frame: From enrollment to the end of the follow-up at 11 weeks
subjective sleep quality measured by the questionnaire PSQI, Minimum score: 0 (best sleep quality), Maximum score: 21 (worst sleep quality).
From enrollment to the end of the follow-up at 11 weeks
Evolution of the quality of life
Time Frame: From enrollment to the end of the follow-up at 11 weeks
measured by Saint George's Hospital Respiratory Questionnaire (SGRQ), minimum score (0): indicates no impairment (best possible health status), maximum score (100): indicates severe impairment (worst possible health status).
From enrollment to the end of the follow-up at 11 weeks
Daytime sleepiness
Time Frame: From enrollment to the end of the follow-up at 11 weeks
measured by Epworth Sleepiness Scale, minimum score of 0 (no daytime sleepiness), maximum score of 24 (severe daytime sleepiness).
From enrollment to the end of the follow-up at 11 weeks
Dyspnée
Time Frame: From enrollment to the end of the follow-up at 11 weeks
measured by the score modified Medical Research Council [mMRC], minimum score of 0 (least severe dyspnea), maximum score of 4 (most severe dyspnea).
From enrollment to the end of the follow-up at 11 weeks
Severity of COPD symptoms
Time Frame: From enrollment to the end of the follow-up at 11 weeks
measured by COPD Assessment Test [CAT]
From enrollment to the end of the follow-up at 11 weeks
Anxiety and depression
Time Frame: From enrollment to the end of the follow-up at 11 weeks
measured by the HAD (Hospital Anxiety and Depression) scale, minimum score of 0 (no symptoms of anxiety or depression), maximum score of 21 (severe symptoms of anxiety or depression).
From enrollment to the end of the follow-up at 11 weeks
exercise capacity
Time Frame: From enrollment to the end of the follow-up at 11 weeks
measured during an maximal exercise test
From enrollment to the end of the follow-up at 11 weeks
6 minutes walking test
Time Frame: From enrollment to the end of the follow-up at 11 weeks
measured by distance walked during 6 minutes.
From enrollment to the end of the follow-up at 11 weeks
Wakefulness after sleep onset
Time Frame: From enrollment to the end of the follow-up at 11 weeks
Wakefulness after sleep onset (WASO) measured by the average of the 2 independent polysomnography readings
From enrollment to the end of the follow-up at 11 weeks
Sleep Efficiency
Time Frame: From enrollment to the end of the follow-up at 11 weeks
Sleep Efficiency measured by the average of the 2 independent polysomnography readings
From enrollment to the end of the follow-up at 11 weeks
Number of awakenings
Time Frame: From enrollment to the end of the follow-up at 11 weeks
Number of awakenings measured by the average of the 2 independent polysomnography readings
From enrollment to the end of the follow-up at 11 weeks
Micro-arousal index
Time Frame: From enrollment to the end of the follow-up at 11 weeks
Micro-arousal index measured by the average of the 2 independent polysomnography readings
From enrollment to the end of the follow-up at 11 weeks
N1 sleep stage
Time Frame: From enrollment to the end of the follow-up at 11 weeks
N1 (%) measured by the average of the 2 independent polysomnography readings
From enrollment to the end of the follow-up at 11 weeks
N2 sleep stage
Time Frame: From enrollment to the end of the follow-up at 11 weeks
N2 (%) measured by the average of the 2 independent polysomnography readings
From enrollment to the end of the follow-up at 11 weeks
N3 sleep stage
Time Frame: From enrollment to the end of the follow-up at 11 weeks
N3 (%) measured by the average of the 2 independent polysomnography readings
From enrollment to the end of the follow-up at 11 weeks
other sleep parameter
Time Frame: From enrollment to the end of the follow-up at 11 weeks
REM (%) (Rapid Eye Movement) measured by the average of the 2 independent polysomnography readings
From enrollment to the end of the follow-up at 11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/0347/HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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