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Protocol PERCAF 2018

I

Institute of Biomedical Research of the Army

Status

Completed

Conditions

Caffeine
Polymorphism
Sleep

Treatments

Other: Sleep deprivation

Study type

Interventional

Funder types

Other

Identifiers

NCT03859882
Protocol PERCAF 2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment

52 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy subject

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

52 participants in 2 patient groups, including a placebo group

Caffeine
Experimental group
Description:
Caffeine 5 mg/kg/day in 2 administration (08:00 and 14:00) per day
Treatment:
Other: Sleep deprivation
placebo
Placebo Comparator group
Description:
in 2 administration (08:00 and 14:00) per day
Treatment:
Other: Sleep deprivation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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