Protocol PERCAF 2018

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sleep, Caffeine, Polymorphism

Intervention / Treatment
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* Other: Sleep deprivation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy subject Exclusion Criteria: Treatment History of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease Nonvoluntary Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caffeine<br>Caffeine 5 mg/kg/day in 2 administration (08:00 and 14:00) per day | Other: Sleep deprivation<br>* 40 hours of continuous awaking in the sleep laboratory in order to compare before and after sleep deprivation for each treatment (Caffeine vs. placebo).<br>|
| Placebo Comparator: placebo<br>in 2 administration (08:00 and 14:00) per day | Other: Sleep deprivation<br>* 40 hours of continuous awaking in the sleep laboratory in order to compare before and after sleep deprivation for each treatment (Caffeine vs. placebo).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor vigilance test Speed | Speed at the Psychomotor vigilance test test | Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance | Number of errors at executive performance test | Change from Baseline at day 2 after 25 hours awaking | 
| Force -velocity | Power at the force-velocity test | Change from Baseline at day 2 after 32 hours awaking | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep deprivation, cognition, attention