Respiratory Rehabilitation and Sleep Quality in COPD Patients

NCT06677268 | Recruiting

• 1 other identifier: 2022/0347/HP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

polysomnography; sleep quality; physical activity; education; respiratory rehabilitation

Outcome Measures

Primary Outcomes (1)

• Total sleep time (TST)

  measured by the average of the 2 independent polysomnography scorings

  Baseline and end of respiratory rehabilitation (2 months)

Secondary Outcomes (17)

• Sleep onset latency

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

• Pittsburgh sleep quality index (PSQI)

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

• Evolution of the quality of life

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

• Daytime sleepiness

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

• Dyspnée

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

Study Arms (2)

Respiratory Rehabilitation

EXPERIMENTAL

Patient in this arm will perform a 2-months respiratory rehabilitation program

Procedure: Rehabilitation

Usual care

NO INTERVENTION

Patient in the control group (usual care) will have standard care without respiratory rehabilitation program

Interventions

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)

Respiratory Rehabilitation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient who has read and understood the information letter and signed the consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (4)

Chu Amiens

Amiens, 80054, France

NOT YET RECRUITING

Gh Le Havre

Le Havre, 76083, France

NOT YET RECRUITING

Centre de Sante Adir

Rouen, 76000, France

NOT YET RECRUITING

Chu Rouen

Rouen, 76031, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Initiation and Maintenance Disorders; Motor Activity

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Marie-Anne Melone, MD, PhD

CONTACT

(+33) 0232888265; marieanne.melone@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators analyzing the polysomnography and total sleep time (primary endpoint) will be blinded of the group in which the patient is randomized.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, controled, interventional, multi center

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: November 6, 2024
• Study Start: February 19, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

FR (4)