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临床试验/NCT00487292
NCT00487292已完成不适用

The Effects of a Combination of Napping and Bright Light Pulses on Shift Workers Sleepiness at the Wheel A Pilot Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2003年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
EEG sleepiness at the wheel

研究概览

简要总结

Design: paired trials without and with naps and bright light. Setting: Real driving on a private road circuit. Environmental controlled car. Participants: 9 shift workers on tree shifts (morning-afternoon-night) Measurements: Sleepiness at the wheel was measured by ambulatory polysomnography and assessed using 30 seconds segments of recordings when the percentage of theta EEG was at least 50% (15 seconds) of the period recorded. Subjects were also called to rate their sleepiness on the 7-point Stanford Sleepiness Scale (SSS).

Intervention: Participants drove the same car on two similar 24 hours periods of work, with three pilots in each shift (morning, afternoon, night), separated by three weeks. During the baseline period, the subjects were told to manage their rest as they usually do in the real life. During the second experimental period, they had to rest lied in a dark room during two naps of 20 minutes and then exposed to bright light pulse (5000 lux) during 10 minutes.

详细描述

Results are submitted to publication

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •A professional experience of at least one year

排除标准

  • •With an history of chronic disease,treatments (or toxic)
  • •Subjects with a suspicion of sleep disorders

结局指标

主要结局

EEG sleepiness at the wheel

时间窗: two periods of 8 hours driving

次要结局

  • subjective sleepiness at the stanford sleepinesss scale(two periods of 8 hours driving)

研究者

申办方类型
Other

研究点 (1)

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