跳至主要内容
临床试验/NCT02725190
NCT02725190已完成不适用

Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年4月1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
入组人数
20
试验地点
1
主要终点
Time, in minutes, measured from the beginning of the inspiratory endurance test and the end, defined by the patient's wish to stop.

研究概览

简要总结

The purpose of this study is to assess the impact of sleep deprivation on subjective inspiratory endurance in healthy subjects.

详细描述

Sleep in intensive care unit is altered and few studies have suggested that sleep deprivation (SD) could impact respiratory muscle endurance. A lack of inspiratory endurance could lengthen weaning from invasive ventilation. The purpose of this study is to confirm whether SD alters inspiratory endurance and to identify brain mechanisms involved in SD-induced decreased endurance. A group of 20 male healthy subjects will perform an inspiratory load trial after a normal sleep night and after a sleepless night. Electrophysiological parameters (EEG, motor evoked potentials) of the inspiratory motor command and sensory perceptions will be assessed before, during and after each trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Male adult volunteers
  • •Aged 25 to 45 years
  • •Regularly sleeping more than 6 hours per night
  • •Not excessive coffee consumers (< 3 expressos / day)
  • •Non smokers
  • •Absence of respiratory, cardiac, muscular or neurological disease or diabetes
  • •With a neutral Horne & Ostberg score

排除标准

  • •Previous history of respiratory disease or otorhinolaryngological (asthma, respiratory allergies, swallowing disorders, oropharyngeal malformations)
  • •History of epilepsy or syncope during sleep deprivation
  • •Taking medications that interfere with sleep (antidepressants, benzodiazepines...)

研究组 & 干预措施

Group 1

Other

Normal sleep night.

干预措施: Normal sleep night (Behavioral)

Group 2

Other

Sleepless night.

干预措施: Sleepless night (Behavioral)

结局指标

主要结局

Time, in minutes, measured from the beginning of the inspiratory endurance test and the end, defined by the patient's wish to stop.

时间窗: The day after one normal night or one sleepless night.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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