Clinical trial NCT03859882: Protocol PERCAF 2018
Official title: Polymorphisms and Efficiency of Caffeine on Performances During Total Sleep Deprivation un Healthy Subject. Multicentric, Versus Placebo, Randomised, Cross Over, Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Caffeine
Polymorphism
Keywords: sleep deprivation
cognition
attention
Lead sponsor: Institut de Recherche Biomedicale des Armees
Sponsor class: OTHER_GOV
First posted: 2019-03-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* healthy subject

Exclusion Criteria:

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

Primary outcomes:
measure: Psychomotor vigilance test Speed
timeFrame: Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking
Secondary outcomes:
measure: Cognitive performance
timeFrame: Change from Baseline at day 2 after 25 hours awaking
measure: Force -velocity
timeFrame: Change from Baseline at day 2 after 32 hours awaking
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de recherche biomedical des armées
city: Paris
country: France
facility: Hotel Dieu
Study officials:
References:
citation: 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.
citation: 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.