Evaluation of Sleep Schedules Modifications in Moderate to Severe Sleep Apnea Patients Treated by nCPAP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients
研究概览
简要总结
In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with continuous positive airway pressure (CPAP) therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients.
详细描述
In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with CPAP therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Patients often report this fact, but it has not been objectivated.
Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients. Sleep schemes and physical activity will be studied with actigraphy.
Study Design : prospective study. Number of patients supposed to be studied: 190
Methods:
Patients Ø OSA patients assessed by polysomnography, showing apnea-hypopnea index > 20, and Epworth Sleepiness Scale Score(ESS) >10 Ø Indication of CPAP therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe OSA
- •sleepy (sleepiness assessed by Epworth Sleepiness Scale)
- •indication for CPAP therapy
排除标准
- •narcolepsy
- •age < 18
- •non sleepy Moderate to severe OSA
- •no CPAP treatment required
结局指标
主要结局
Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients
时间窗: baseline and at 3 months
change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy
次要结局
- Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients(baseline and at 3 months)
研究者
Marie Bruyneel
chef de clinique adjoint
Centre Hospitalier Universitaire Saint Pierre