Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06677268

Respiratory Rehabilitation and Sleep Quality in COPD Patients

Led by University Hospital, Rouen · Updated on 2026-02-18

90

Participants Needed

4

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Respiratory Rehabilitation and Sleep Quality in COPD Patients

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 50 years or older
  • Clinically stable COPD diagnosed by GOLD 2022 criteria, with no exacerbation for at least 4 weeks
  • Indication for respiratory rehabilitation
  • No respiratory rehabilitation in the past 12 months
  • Affiliated to the social security system
  • For women of childbearing potential, use of effective contraception for at least 1 month
  • For postmenopausal women, confirmed diagnosis with non-medically induced amenorrhea for at least 12 months
  • Ability to read, understand the information, and sign the consent form
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) of 30 kg/m2 or higher
  • Previously diagnosed obstructive sleep apnea with apnea-hypopnea index greater than 10 per hour
  • Use of CPAP or non-invasive ventilation
  • Current systemic corticosteroid therapy
  • Use of centrally acting drugs such as benzodiazepines or opiates
  • History of severe COPD exacerbation
  • Other chronic respiratory insufficiency
  • Active cancer
  • Neuromuscular disease
  • Osteoarticular disability, trauma, or neurological condition preventing participation in rehabilitation
  • Psychiatric, cognitive, or language disorders preventing protocol understanding or adherence
  • Contraindications to respiratory rehabilitation or any condition preventing physical rehabilitation
  • Cardiovascular contraindications to respiratory rehabilitation
  • Legal restrictions such as imprisonment or judicial guardianship
  • Pregnancy, childbirth, or breastfeeding

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Chu Amiens

Amiens, France, 80054

Not Yet Recruiting

2

Gh Le Havre

Le Havre, France, 76083

Not Yet Recruiting

3

Centre de Sante Adir

Rouen, France, 76000

Not Yet Recruiting

4

Chu Rouen

Rouen, France, 76031

Actively Recruiting

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Research Team

M

Marie-Anne Melone, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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