Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

Find Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials Near You

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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Amiens
NOT_YET_RECRUITING
Amiens
Gh Le Havre
NOT_YET_RECRUITING
Le Havre
Centre de Sante Adir
NOT_YET_RECRUITING
Rouen
Chu Rouen
RECRUITING
Rouen
Contact Information
Primary
Marie-Anne Melone, MD, PhD
marieanne.melone@chu-rouen.fr
(+33) 0232888265
Time Frame
Start Date: 2025-02-19
Estimated Completion Date: 2028-02
Participants
Target number of participants: 90
Treatments
Experimental: Respiratory Rehabilitation
Patient in this arm will perform a 2-months respiratory rehabilitation program
No_intervention: Usual care
Patient in the control group (usual care) will have standard care without respiratory rehabilitation program
Sponsors
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov