Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06677268

Respiratory Rehabilitation and Sleep Quality in COPD Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation

Procedure

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)

Primary outcomes

  1. Total sleep time (TST)

    Time frame: Baseline and end of respiratory rehabilitation (2 months)

    measured by the average of the 2 independent polysomnography scorings

Secondary outcomes

  1. 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

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. Severity of COPD symptoms

    Time frame: From enrollment to the end of the follow-up at 11 weeks

    measured by COPD Assessment Test [CAT]

  7. 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).

  8. exercise capacity

    Time frame: From enrollment to the end of the follow-up at 11 weeks

    measured during an maximal exercise test

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Anne Melone, MD, PhD

CONTACT

[email protected]

(+33) 0232888265

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: REARSOM/BPCO

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 6, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.