Protocol PERCAF 2018

Not Applicable

Completed

• Conditions: Caffeine; Sleep; Polymorphism
• Interventions: Other: Sleep deprivation

• Registration Number: NCT03859882
• Lead Sponsor: Institut de Recherche Biomedicale des Armees

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-09-02
• Primary Completion: 2018-09-03
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Study Completion: 2019-06-26
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• healthy subject

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Sleep deprivation	in 2 administration (08:00 and 14:00) per day
Caffeine	Sleep deprivation	Caffeine 5 mg/kg/day in 2 administration (08:00 and 14:00) per day

Primary Outcome Measures

Name	Time	Method
Psychomotor vigilance test Speed	Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking	Speed at the Psychomotor vigilance test test

Secondary Outcome Measures

Name	Time	Method
Force -velocity	Change from Baseline at day 2 after 32 hours awaking	Power at the force-velocity test
Cognitive performance	Change from Baseline at day 2 after 25 hours awaking	Number of errors at executive performance test

Trial Locations

Locations (2)

Institut de recherche biomedical des armées; 🇫🇷 Brétigny-sur-Orge, France

Hotel Dieu; 🇫🇷 Paris, France