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Completed

NCT Number: NCT03859882

Protocol PERCAF 2018

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.

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Key information

Conditions

Sleep Caffeine Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Polymorphism Signs and Symptoms Sleep Deprivation Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy subject

Exclusion criteria

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

Treatment and study plan

Sleep deprivation

Other

40 hours of continuous awaking in the sleep laboratory in order to compare before and after sleep deprivation for each treatment (Caffeine vs. placebo).

Primary outcomes

  1. Psychomotor vigilance test Speed

    Time frame: Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking

    Speed at the Psychomotor vigilance test test

Secondary outcomes

  1. Cognitive performance

    Time frame: Change from Baseline at day 2 after 25 hours awaking

    Number of errors at executive performance test

  2. Force -velocity

    Time frame: Change from Baseline at day 2 after 32 hours awaking

    Power at the force-velocity test

Sponsors and collaborators

Lead sponsor

Institut de Recherche Biomedicale des Armees

Other Gov

Registry information

Official study title

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

Acronym: PERCAF

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 1, 2019
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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