Respiratory Rehabilitation and Sleep Quality in COPD Patients

Last updated: February 16, 2026
Sponsor: University Hospital, Rouen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Copd (Chronic Obstructive Pulmonary Disease)

Treatment

rehabilitation

Rehabilitation

Clinical Study ID

NCT06677268
2022/0347/HP
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female ≥ age 50

  • COPD defined according to the GOLD 2022 criteria, clinically stable (withoutexacerbation 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 amenorrheafor at least 12 months prior to the inclusion visit)

  • Patient who has read and understood the information letter and signed the consentform

Exclusion

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 sequelaepreventing participation in the respiratory rehabilitation program

  • Psychiatric, cognitive or linguistic disorders with inability to understand tofollow the protocol

  • Patient with a contraindication to respiratory rehabilitation or any pathologypreventing physical rehabilitation

  • Patient with a cardiovascular contraindication to respiratory rehabilitation

  • Person deprived of liberty by an administrative or judicial decision or personplaced under judicial safeguard, guardianship or curatorship

  • Person subject to a legal protection measure

  • Pregnant or parturient or breastfeeding woman

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: rehabilitation
Phase:
Study Start date:
February 19, 2025
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Chu Amiens

    Amiens 3037854, 80054
    France

    Site Not Available

  • Gh Le Havre

    Le Havre 3003796, 76083
    France

    Site Not Available

  • Centre de Sante Adir

    Rouen 2982652, 76000
    France

    Site Not Available

  • Chu Rouen

    Rouen 2982652, 76031
    France

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.