Protocol PERCAF 2018

NCT ID: NCT03859882

Last Updated: 2021-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-02

Study Completion Date

2019-06-26

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.

Conditions

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Sleep Caffeine Polymorphism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Caffeine

Caffeine 5 mg/kg/day in 2 administration (08:00 and 14:00) per day

Group Type EXPERIMENTAL

Sleep deprivation

Intervention Type 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).

placebo

in 2 administration (08:00 and 14:00) per day

Group Type PLACEBO_COMPARATOR

Sleep deprivation

Intervention Type 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).

Interventions

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Sleep 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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy subject

Exclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut de Recherche Biomedicale des Armees

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de recherche biomedical des armées

Brétigny-sur-Orge, , France

Site Status

Hotel Dieu

Paris, , France

Site Status

Countries

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France

References

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de Lorgeril B, Tardo-Dino PE, Bourrilhon C, Quiquempoix M, Drogou C, Mateo L, Erblang M, Colin P, Van Beers P, Chennaoui M, Gomez-Merino D, Sauvet F. Impact of acute caffeine intake on local tolerance to cold before and after total sleep deprivation. Exp Physiol. 2025 Sep;110(9):1254-1270. doi: 10.1113/EP092356. Epub 2025 Mar 27.

Reference Type DERIVED
PMID: 40150834 (View on PubMed)

Pauchon B, Beauchamps V, Gomez-Merino D, Erblang M, Drogou C, Beers PV, Guillard M, Quiquempoix M, Leger D, Chennaoui M, Sauvet F. Caffeine Intake Alters Recovery Sleep after Sleep Deprivation. Nutrients. 2024 Oct 11;16(20):3442. doi: 10.3390/nu16203442.

Reference Type DERIVED
PMID: 39458438 (View on PubMed)

Drogou C, Sauvet F, Erblang M, Leger D, Thomas C, Chennaoui M, Gomez-Merino D; Investigators group. Effects of Acute Caffeine Intake on Insulin-Like Growth Factor-1 Responses to Total Sleep Deprivation: Interactions with COMT Polymorphism - A Randomized, Crossover Study. Lifestyle Genom. 2023;16(1):113-123. doi: 10.1159/000529897. Epub 2023 Jun 6.

Reference Type DERIVED
PMID: 37279709 (View on PubMed)

Erblang M, Drogou C, Gomez-Merino D, Rabat A, Guillard M, Beers PV, Quiquempoix M, Boland A, Deleuze JF, Olaso R, Derbois C, Prost M, Dorey R, Leger D, Thomas C, Chennaoui M, Sauvet F. Genetics and Cognitive Vulnerability to Sleep Deprivation in Healthy Subjects: Interaction of ADORA2A, TNF-alpha and COMT Polymorphisms. Life (Basel). 2021 Oct 19;11(10):1110. doi: 10.3390/life11101110.

Reference Type DERIVED
PMID: 34685481 (View on PubMed)

Erblang M, Sauvet F, Drogou C, Quiquempoix M, Van Beers P, Guillard M, Rabat A, Trignol A, Bourrilhon C, Erkel MC, Leger D, Thomas C, Gomez-Merino D, Chennaoui M. Genetic Determinants of Neurobehavioral Responses to Caffeine Administration during Sleep Deprivation: A Randomized, Cross Over Study (NCT03859882). Genes (Basel). 2021 Apr 10;12(4):555. doi: 10.3390/genes12040555.

Reference Type DERIVED
PMID: 33920292 (View on PubMed)

Other Identifiers

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Protocol PERCAF 2018

Identifier Type: -

Identifier Source: org_study_id

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