Reliability of Automatic CPAP Devices. A Double Blind Dummy Controlled Phase 1 Study
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Obstructive Sleep Apnea
- 发起方
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained
- 状态
- 已完成
- 最后更新
- 16年前
概览
简要总结
Background: In patients with obstructive sleep apnea, automatic continuous positive airway pressure machines (autoCPAP) are said to be capable of identifying various breathing abnormalities during sleep and to correct them by increasing progressively the positive pressure applied to the airway. Once breathing becomes normal, pressure slowly declines. AutoCPAP devices have never been tested in Phase I studies. The investigators hypothesised that normal breathing would not be recognised as such, and that pressure would increase even in a normal subject.
详细描述
Material and Methods: We will submit one normal (confirmed with two polysomnographies, PSG) subject to a double blind study. Pairs of PSG will be performed on successive days once a week, one night with a 4 cm water fixed pressure CPAP device, previously shown not to disturb the subject's sleep and breathing, the other night with one of five well known autoCPAP devices programmed to work between 4 and 15 cm H2O pressure. The same mask and headgear will be used throughout the study. The subject and the physicians reading the tracings will ignore which device is being used on which night.
研究者
入排标准
入选标准
- •normal subject
- •male and female
- •age 18 to 65 years old
排除标准
- •obstructive sleep apnea
- •unable to sleep with a CPAP device
结局指标
主要结局
number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained
时间窗: one night
次要结局
- reasons for pressure increase and consequences of the increase on sleep continuity(one night)