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临床试验/NCT03859882
NCT03859882已完成不适用

Polymorphisms and Efficiency of Caffeine on Performances During Total Sleep Deprivation un Healthy Subject. Multicentric, Versus Placebo, Randomised, Cross Over, Double Blind Study

Institut de Recherche Biomedicale des Armees3 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年9月2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
52
试验地点
3
主要终点
Psychomotor vigilance test Speed

研究概览

简要总结

In this multicentric controlled study, we aims to evaluate effect of caffeine on mental performances during a sleep deprivation protocol. Genetic polymorphisms are considered as a covariable.

详细描述

Coffee is the most consumed arousing substance in the world. Caffeine is used as a natural countermeasure to maintain the performance of sleep deprived subjects. However, the effectiveness of caffeine is characterized by a large individual variability, also observed on side effects. This variability could notably be related to polymorphisms of the adenosine receptor 2a gene (ADORA2A) and Tumor Necrosis Factor-alpha, a pro-inflammatory cytokine whose increase is observed during sleep deprivation.

This study, under conditions of total sleep deprivation in the laboratory (40 hours of continuous awakening), examine the cross-influence of two polymorphisms (ADORA2A: rs5751876 and TNF-alpha: rs1800629) on the sensitivity to caffeine and on the degradation of attentional performances. Physical performance, mental performance, immuno-inflammatory responses and the occurrence indesirable effects will be evaluate.

This work aims to understand the mechanisms that contribute to increasing individual vulnerability and promoting protective countermeasures. The purpose of this project is to improve the recommendations concerning the daily use of caffeine and during periods of prolonged awakening, particularly in the military environment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy subject

排除标准

  • Treatment
  • History of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease
  • Nonvoluntary
  • Pregnancy

结局指标

主要结局

Psychomotor vigilance test Speed

时间窗: Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking

Speed at the Psychomotor vigilance test test

次要结局

  • Force -velocity(Change from Baseline at day 2 after 32 hours awaking)
  • Cognitive performance(Change from Baseline at day 2 after 25 hours awaking)

研究者

发起方
Institut de Recherche Biomedicale des Armees
申办方类型
Other Gov
责任方
Sponsor

研究点 (3)

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