NCT03053011已完成不适用
Alarm Relay Bracelet for Simplification and Security Respiratory Assistance at Home: Evaluation of the Nocturnal Awakening Capability in Ventilated Patients and Healthy Volunteers
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年2月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Total awakening capability
研究概览
简要总结
As part of developing a relay alarm project, the aim of the study is to test a sleeper's capability to wake up via a vibrating alarm around the wrist (vibrating bracelet).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •speak french
- •with social security For healthy volunteers : no sleep disorder, known neurological or respiratory pathology For patients : congenital central hypoventilation syndrome or ventilatory assistance whatever the indication, able to act on their ventilator, and in stable state on the respiratory level for at least 3 months.
排除标准
- •subjects taking treatment that may interfere with sleep patterns
- •intake of alcohol or any substance (alcohol, drugs) that may interfere with sleep patterns the day before the polysomnography
研究组 & 干预措施
Vibrating bracelet
Experimental
A bracelet with vibrations triggered randomly overnight
干预措施: Vibrating bracelet (Other)
结局指标
主要结局
Total awakening capability
时间窗: 1 night
Proportion of the activations of the bracelet causing an awakening sufficient for the subject to stop the application and do a cognitive task : note the wake-up time
次要结局
- Awakening capability in each stage of sleep(1 night)
- Awakening without capability to do the cognitive task(1 night)
研究者
研究点 (2)
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