Protocol PERCAF 2018

Sleep Clinical Trial

— PERCAF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859882
• Other study ID #: Protocol PERCAF 2018
• Status: Completed
• Phase: N/A
• Start date: September 2, 2018
• Est. completion date: June 26, 2019

Study information

• Verified date: August 2021
• Source: Institut de Recherche Biomedicale des Armees
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 26, 2019
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy subject

Exclusion Criteria:

• Treatment

• History of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease

• Nonvoluntary

• Pregnancy

Related Conditions & MeSH terms

• Caffeine
• Polymorphism
• Sleep
• Sleep Deprivation

Intervention

Other:
• 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).

Locations

Country	Name	City	State
France	Institut de recherche biomedical des armées	Brétigny-sur-Orge
France	Hotel Dieu	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherche Biomedicale des Armees

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychomotor vigilance test Speed	Speed at the Psychomotor vigilance test test	Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking
Secondary	Cognitive performance	Number of errors at executive performance test	Change from Baseline at day 2 after 25 hours awaking
Secondary	Force -velocity	Power at the force-velocity test	Change from Baseline at day 2 after 32 hours awaking