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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory Rehabilitation | Experimental | Patient in this arm will perform a 2-months respiratory rehabilitation program |
|
| Usual care | No Intervention | Patient in the control group (usual care) will have standard care without respiratory rehabilitation program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Total sleep time (TST) | measured by the average of the 2 independent polysomnography scorings | Baseline and end of respiratory rehabilitation (2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep onset latency | Sleep onset latency (SOL) measured by the average of the 2 independent polysomnography readings | From enrollment to the end of the follow-up at 11 weeks |
| Pittsburgh sleep quality index (PSQI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Anne Melone, MD, PhD | Contact | (+33) 0232888265 | marieanne.melone@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens | Not yet recruiting | Amiens | 80054 | France |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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randomized, controled, interventional, multi center
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Investigators analyzing the polysomnography and total sleep time (primary endpoint) will be blinded of the group in which the patient is randomized.
subjective sleep quality measured by the questionnaire PSQI, Minimum score: 0 (best sleep quality), Maximum score: 21 (worst sleep quality).
| From enrollment to the end of the follow-up at 11 weeks |
| Evolution of the quality of life | 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). | From enrollment to the end of the follow-up at 11 weeks |
| Daytime sleepiness | measured by Epworth Sleepiness Scale, minimum score of 0 (no daytime sleepiness), maximum score of 24 (severe daytime sleepiness). | From enrollment to the end of the follow-up at 11 weeks |
| Dyspnée | measured by the score modified Medical Research Council [mMRC], minimum score of 0 (least severe dyspnea), maximum score of 4 (most severe dyspnea). | From enrollment to the end of the follow-up at 11 weeks |
| Severity of COPD symptoms | measured by COPD Assessment Test [CAT] | From enrollment to the end of the follow-up at 11 weeks |
| Anxiety and depression | 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). | From enrollment to the end of the follow-up at 11 weeks |
| exercise capacity | measured during an maximal exercise test | From enrollment to the end of the follow-up at 11 weeks |
| 6 minutes walking test | measured by distance walked during 6 minutes. | From enrollment to the end of the follow-up at 11 weeks |
| Wakefulness after sleep onset | Wakefulness after sleep onset (WASO) measured by the average of the 2 independent polysomnography readings | From enrollment to the end of the follow-up at 11 weeks |
| Sleep Efficiency | Sleep Efficiency measured by the average of the 2 independent polysomnography readings | From enrollment to the end of the follow-up at 11 weeks |
| Number of awakenings | Number of awakenings measured by the average of the 2 independent polysomnography readings | From enrollment to the end of the follow-up at 11 weeks |
| Micro-arousal index | Micro-arousal index measured by the average of the 2 independent polysomnography readings | From enrollment to the end of the follow-up at 11 weeks |
| N1 sleep stage | N1 (%) measured by the average of the 2 independent polysomnography readings | From enrollment to the end of the follow-up at 11 weeks |
| N2 sleep stage | N2 (%) measured by the average of the 2 independent polysomnography readings | From enrollment to the end of the follow-up at 11 weeks |
| N3 sleep stage | N3 (%) measured by the average of the 2 independent polysomnography readings | From enrollment to the end of the follow-up at 11 weeks |
| other sleep parameter | REM (%) (Rapid Eye Movement) measured by the average of the 2 independent polysomnography readings | From enrollment to the end of the follow-up at 11 weeks |
| Gh Le Havre | Not yet recruiting | Le Havre | 76083 | France |
|
| Centre de Sante Adir | Not yet recruiting | Rouen | 76000 | France |
|
| Chu Rouen | Recruiting | Rouen | 76031 | France |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |