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Protocol PERCAF 2018

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03859882
Acronym
PERCAF
Enrollment
52
Registered
2019-03-01
Start date
2018-09-02
Completion date
2019-06-26
Last updated
2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caffeine, Polymorphism, Sleep

Keywords

sleep deprivation, cognition, attention

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.

Interventions

OTHERSleep deprivation

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

Sponsors

Institut de Recherche Biomedicale des Armees
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy subject

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Psychomotor vigilance test SpeedChange from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awakingSpeed at the Psychomotor vigilance test test

Secondary

MeasureTime frameDescription
Cognitive performanceChange from Baseline at day 2 after 25 hours awakingNumber of errors at executive performance test
Force -velocityChange from Baseline at day 2 after 32 hours awakingPower at the force-velocity test

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026