COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
polysomnography, sleep quality, physical activity, education, respiratory rehabilitation
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.
Interventions
PROCEDURERehabilitation
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)
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Investigators analyzing the polysomnography and total sleep time (primary endpoint) will be blinded of the group in which the patient is randomized.
Intervention model description
randomized, controled, interventional, multi center
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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 \> 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total sleep time (TST) | Baseline and end of respiratory rehabilitation (2 months) | measured by the average of the 2 independent polysomnography scorings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep onset latency | From enrollment to the end of the follow-up at 11 weeks | Sleep onset latency (SOL) measured by the average of the 2 independent polysomnography readings |
| Pittsburgh sleep quality index (PSQI) | From enrollment to the end of the follow-up at 11 weeks | subjective sleep quality measured by the questionnaire PSQI, Minimum score: 0 (best sleep quality), Maximum score: 21 (worst sleep quality). |
| Evolution of the quality of life | From enrollment to the end of the follow-up at 11 weeks | measured by Saint George's Hospital Respiratory Questionnaire (SGRQ), minimum score (0): indicates no impairment (best possible health status), maximum score (100): indicates severe impairment (worst possible health status). |
| Daytime sleepiness | From enrollment to the end of the follow-up at 11 weeks | measured by Epworth Sleepiness Scale, minimum score of 0 (no daytime sleepiness), maximum score of 24 (severe daytime sleepiness). |
| Dyspnée | From enrollment to the end of the follow-up at 11 weeks | measured by the score modified Medical Research Council \[mMRC\], minimum score of 0 (least severe dyspnea), maximum score of 4 (most severe dyspnea). |
| Severity of COPD symptoms | From enrollment to the end of the follow-up at 11 weeks | measured by COPD Assessment Test \[CAT\] |
| Anxiety and depression | From enrollment to the end of the follow-up at 11 weeks | measured by the HAD (Hospital Anxiety and Depression) scale, minimum score of 0 (no symptoms of anxiety or depression), maximum score of 21 (severe symptoms of anxiety or depression). |
| exercise capacity | From enrollment to the end of the follow-up at 11 weeks | measured during an maximal exercise test |
| 6 minutes walking test | From enrollment to the end of the follow-up at 11 weeks | measured by distance walked during 6 minutes. |
| Wakefulness after sleep onset | From enrollment to the end of the follow-up at 11 weeks | Wakefulness after sleep onset (WASO) measured by the average of the 2 independent polysomnography readings |
| Sleep Efficiency | From enrollment to the end of the follow-up at 11 weeks | Sleep Efficiency measured by the average of the 2 independent polysomnography readings |
| Number of awakenings | From enrollment to the end of the follow-up at 11 weeks | Number of awakenings measured by the average of the 2 independent polysomnography readings |
| Micro-arousal index | From enrollment to the end of the follow-up at 11 weeks | Micro-arousal index measured by the average of the 2 independent polysomnography readings |
| N1 sleep stage | From enrollment to the end of the follow-up at 11 weeks | N1 (%) measured by the average of the 2 independent polysomnography readings |
| N3 sleep stage | From enrollment to the end of the follow-up at 11 weeks | N3 (%) measured by the average of the 2 independent polysomnography readings |
| N2 sleep stage | From enrollment to the end of the follow-up at 11 weeks | N2 (%) measured by the average of the 2 independent polysomnography readings |
| other sleep parameter | From enrollment to the end of the follow-up at 11 weeks | REM (%) (Rapid Eye Movement) measured by the average of the 2 independent polysomnography readings |
Countries
France
Contacts
CONTACTMarie-Anne Melone, MD, PhD
Outcome results
None listed