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临床试验/NCT02478528
NCT02478528已完成不适用

Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
Analysis of the circadian variation of melatonin and cortisol secretion

研究概览

简要总结

Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact at the individual level but also social and economic level (loss of productivity, morbidity, mortality) emphasize the need for one hand, to improve the investigators' understanding of these disorders in order to develop appropriate therapeutic tools and on the other hand, to increase the investigators' support abilities of patients with these disorders.

The investigators' team of unity sleep from Strasbourg University Hospitals, in collaboration with the UPR 3212 CNRS team, is working on the development and adjustment of new concepts and tools to compensate the investigators' sleep debt in order to apply them to patients with sleep disorders and persons who face with sleep restriction.

研究设计

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

入选标准

  • Man or woman
  • Age from 18 to 40 years
  • With a Body Mass Index (BMI) between 17 and 30 kg m-2
  • Healthy volunteer determined by clinical examination and psychological interview
  • Agreeing to abstain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs, the week before the start of Stage 2 of the study until the end of the study
  • Dated and signed informed consent
  • Subjet affiliated to a social security scheme
  • Subject has been informed about the results of the medical examination

排除标准

  • Participation in other clinical trials in the month preceding the inclusion
  • Shift work in the year before inclusion
  • Cons-indications to the use of the medical device
  • Ocular disease
  • Unable to give informations to the subject (subject in an emergency situation, difficulties in understanding, ...)
  • Subjet under judicial protection
  • Subject under guardianship or curatorship
  • pregnancy
  • breastfeeding

结局指标

主要结局

Analysis of the circadian variation of melatonin and cortisol secretion

时间窗: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition

cortisol and melatonin dosage

Analysis of the perception of fatigue

时间窗: Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition

Karolinska Sleepiness Scale 3 sessions :

次要结局

  • Cognitive performance(Compare during the 3 sessions : energy-light lamp, luminettes lamp and control condition)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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