Clinical trial NCT06677268: Respiratory Rehabilitation and Sleep Quality in COPD Patients
Official title: Benefit of Respiratory Rehabilitation on Objective Sleep Quality in Patients with Stable COPD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: polysomnography
sleep quality
physical activity
education
respiratory rehabilitation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controled, interventional, multi center
Primary purpose: OTHER

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.


Eligibility criteria: 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 \&gt; 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

Primary outcomes:
measure: Total sleep time (TST)
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
Secondary outcomes:
measure: Sleep onset latency
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: Quality of Life
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: Daytime sleepiness
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: Dyspnée
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: Severity of COPD symptoms
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: Anxiety and depression
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: exercise capacity
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: 6 minutes walking test
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group
measure: Wakefulness after sleep onset
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: Sleep Efficiency
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: Number of awakenings
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: Micro-arousal index
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: N1 sleep stage
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: N2 sleep stage
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: N3 sleep stage
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
measure: other sleep parameter
timeFrame: at baseline and after the respiratory rehabilitation program in the interventional group (2.5 months) and after 2 months of usual care in the control group.
Other outcomes:
Locations:
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