Early Sleep Apnea Termination Using Sound Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Differences in sleep apnea associted oxygen desaturations
研究概览
简要总结
Current evidence suggest that sleep apnea-associated oxygen desaturations may induce cardiovascular morbidities in the long term, whereas arousals associated with sleep apneas seem to induce mainly transient nocturnal hypertension. Reducing the occurrence and the magnitude of sleep apnea-associated oxygen desaturations could therefore have a beneficial effect on sleep apnea-associated comobidities. Since sleep apneas usually end with an arousal allowing pharyngeal muscles reactivation, a treatment option could consist of generating an early short awakening to anticipate apnea termination and decrease the risk of oxygen desaturation. The aim of this study is thus to determine if an early sleep apnea termination through the emission of a sound can achieve lower oxygen desaturations compared with "untreated" sleep apneas.
详细描述
The aim of the study is to determine the effect of short sound stimulations on sleep apnea associated desaturations
20 OSA subjects will be recruited and studied with polysomnography and a head band allowing to emit short sound stimulations during sleep. the study will take nplace at the Center for investigation and research in sleep (CIRS)
The magnitude of oxygen desaturations following apnea with and without sound stimulations will be compared. The effects of different types of sound stimulations on the magnitude of cortical and autonomic reactions will also be studied as well as the patients' subjective perception of the sounds.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Able to give informed consent as documented by signature
- •Apnea / hypopnea index > 30 / h (severe)
- •Obstructive Apnea Index > 15 / h
- •Mean amplitude of desaturations (during diagnostic night) ≥ 5%
排除标准
- •Perception deafness
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
- •Professional drivers
研究组 & 干预措施
Apneas with and without intervention
Each patient will be his own control.
干预措施: Sound stimulation (Other)
结局指标
主要结局
Differences in sleep apnea associted oxygen desaturations
时间窗: During the polysomnography night
Differences in the magnitude of blood oxygen desaturation between treated and untreated sleep apnea events (in % of SaO2)
次要结局
- Percentage of sound stimulations associated with autonomic arousals (%)(During the polysomnography night)
- Duration of the apnea (seconds)(During the polysomnography night)
- Magnitude of autonomic reactions (% of pulse wave amplitude drop)(During the polysomnography night)
- Percentage of sound stimulations associated with cortical and subcortical arousals (%)(During the polysomnography night)
- Magnitude of autonomic reactions (duration of pulse wave amplitude drop)(During the polysomnography night)
- Duration of EEG arousals (in seconds)(During the polysomnography night)
研究者
Raphael Heinzer
Professor
University of Lausanne Hospitals