Evolution of Sleep Quality During the Initiation of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome: An Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Duration of deep slow-wave sleep (sleep stage N3) before and after initiation of continuous positive airway pressure (CPAP) treatment.
研究概览
简要总结
Continuous positive airway pressure (CPAP) has a caricatural effect in reducing nocturnal respiratory abnormalities and improving the micro-and macrostructure of sleep. Studies characterizing the improvement of acute sleep parameters after the initiation of CPAP are limited to one or two nights of polysomnographic recording. This is related to the cost of performing these studies with repeated recordings in the laboratory and to the acceptability by patients to perform multiple nights of recordings.
Investigators currently have powerful and reliable methods allowing us to carry out nights at home in the patient's ecosystem, in real-life conditions. The characterization of sleep parameters by these methods is equivalent to a polysomnographic recording.
These technological innovations will allow us to characterize sleep before the initiation of CPAP treatment during several nights performed at home. Investigators will then be able to characterize the kinetics and stability of the improvement of sleep parameters in patients with obstructive sleep apnea syndrome in whom continuous positive airway pressure is initiated.
These data will be original and will serve as exploratory data to judge whether the objective improvement of sleep parameters in the first weeks of treatment is associated with improvement in sleepiness, quality of life, and compliance with treatment.
详细描述
This study aims to evaluate the quality of sleep, principally the deep slow-wave sleep (sleep stage N3) before and after the initiation of continuous positive airway pressure (CPAP) treatment.
70 newly diagnosed patients with OSA requiring CPAP treatment, will be included.
For the study, they will wear the Dreem 3 headband and pulse oximeter at home before initiation of CPAP (for 7 nights) and during the first month of CPAP (for a minimum of 9 nights). They will be also equipped with a glucose sensor and a pedometer during the entire study period before and after CPAP treatment.
Patients will also complete questionnaires about their health status before CPAP treatment (at inclusion) and after one month of treatment
These devices will allow the measurements of different parameters: sleep stages, total sleep time, sleep measures derived from sleep stages, snoring, breathing rate, heart rate head movements, arterial hemoglobin oxygen saturation, pulse rate, continuous subcutaneous glucose level, and physical activity data (average daily steps, average distance walked per day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly diagnosed with OSA requiring CPAP treatment
- •Patients able to use a mobile application on a smartphone or tablet
- •Patients with access to a wi-fi internet connection at home
- •Patients agreeing to remote monitoring of CPAP compliance data by the home care provider
- •Patients who have signed consent to participate in the study
- •Subjects affiliated to a social security
排除标准
- •Patients already treated for OSA
- •Patients treated with a sleep aid (sleeping medications)
- •Patients with severe chronic obstructive or restrictive lung disease with or without oxygen
- •Patients with unstable cardiovascular disease or severe heart failure requiring hospitalization within the last three months or meeting New York Heart Association criteria, Class III or IV disease
- •Subjects listed in articles L1121-5 to L1121-8: pregnant women, feeding and parturients, subjects deprived of liberty by judicial or administrative decision, persons under legal protection
- •Persons in a period of exclusion from another study or ongoing participation in a drug study
- •Subjects likely, at the investigator's discretion, to be uncooperative or noncompliant with the obligations inherent to participation in the study
研究组 & 干预措施
Technological innovations and CPAP
Patients will be equipped with 4 devices: a Dreem 3 Headband, a pulse oximeter, a continuous glucose sensor, and a pedometer. In parallel they will be equipped by the CPAP at home by Icadom.
干预措施: Deem 3 Headband (Device)
结局指标
主要结局
Duration of deep slow-wave sleep (sleep stage N3) before and after initiation of continuous positive airway pressure (CPAP) treatment.
时间窗: 7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation
Time spent on the deep slow-wave sleep stage (stage N3 sleep), recorded by the Dreem 3 headband, from 7 nights before and 9 nights after initiation of CPAP treatment
次要结局
- The percentage of time while sleeping(7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation)
- Duration of the other sleep stages (W, N1, N2 and REM)(7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation)
- Duration of different sleep times(7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation)
- The frequence of snoring while sleeping recorded by Dreem 3 headband(7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation)
- Respiratory rate measurment recorded by Dreem 3 headband(7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation)
- Evolution of the nocturnal oximetry(7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation)
- Average distance walked per day(7 nights before CPAP initiation and for a month after CPAP initiation)
- Sleep quality assessed by Pittsburg questionnaire(At inclusion and a month after CPAP initiation)
- The frequences of sleep waves during the NREM sleep stage recorded by Dreem 3 headband(7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation)
- Average daily number of steps(7 nights before CPAP initiation and for a month after CPAP initiation)
- Severity of insomnia measured by the index sverety of insomnia questionnaire(At inclusion and a month after CPAP initiation)
- Evolution of the quality of life by the Short Form 36 health survey questionnaire(At inclusion and a month after CPAP initiation)
- Evolution of the compliance of CPAP treatment(For a month during CPAP treatment)
- Heart rate measurement while sleepingrecorded by Dreem 3 headband(7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation)
- Evolution of the subcutaneous glucose level(7 nights before CPAP initiation and for a month after CPAP initiation)
- Evolution of glycemia(At inclusion and a month after CPAP initiation)
- Evolution of the somnolence(At inclusion and a month after CPAP initiation)
- Evolution of the effectiveness of CPAP treatment(For a month during CPAP treatment)
- The position of the head changes while sleeping recorded by Dreem 3 headband(7 nights before CPAP initiation and for a month (minimum 9 nights) after CPAP initiation)