Benefit of Respiratory Rehabilitation on Objective Sleep Quality in Patients With Stable COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Total sleep time (TST)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Investigators analyzing the polysomnography and total sleep time (primary endpoint) will be blinded of the group in which the patient is randomized.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Respiratory Rehabilitation
Patient in this arm will perform a 2-months respiratory rehabilitation program
干预措施: Rehabilitation (Procedure)
Usual care
Patient in the control group (usual care) will have standard care without respiratory rehabilitation program
结局指标
主要结局
Total sleep time (TST)
时间窗: Baseline and end of respiratory rehabilitation (2 months)
measured by the average of the 2 independent polysomnography scorings
次要结局
- Micro-arousal index(From enrollment to the end of the follow-up at 11 weeks)
- N1 sleep stage(From enrollment to the end of the follow-up at 11 weeks)
- N2 sleep stage(From enrollment to the end of the follow-up at 11 weeks)
- N3 sleep stage(From enrollment to the end of the follow-up at 11 weeks)
- other sleep parameter(From enrollment to the end of the follow-up at 11 weeks)
- Sleep onset latency(From enrollment to the end of the follow-up at 11 weeks)
- Pittsburgh sleep quality index (PSQI)(From enrollment to the end of the follow-up at 11 weeks)
- Evolution of the quality of life(From enrollment to the end of the follow-up at 11 weeks)
- Daytime sleepiness(From enrollment to the end of the follow-up at 11 weeks)
- Dyspnée(From enrollment to the end of the follow-up at 11 weeks)
- Severity of COPD symptoms(From enrollment to the end of the follow-up at 11 weeks)
- Anxiety and depression(From enrollment to the end of the follow-up at 11 weeks)
- exercise capacity(From enrollment to the end of the follow-up at 11 weeks)
- 6 minutes walking test(From enrollment to the end of the follow-up at 11 weeks)
- Wakefulness after sleep onset(From enrollment to the end of the follow-up at 11 weeks)
- Sleep Efficiency(From enrollment to the end of the follow-up at 11 weeks)
- Number of awakenings(From enrollment to the end of the follow-up at 11 weeks)