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Protocol PERCAF 2018 (PERCAF)

Primary Purpose

Sleep, Caffeine, Polymorphism

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sleep deprivation
Sponsored by
Institut de Recherche Biomedicale des Armees
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep focused on measuring sleep deprivation, cognition, attention

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy subject

Exclusion Criteria:

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

Sites / Locations

  • Institut de recherche biomedical des armées
  • Hotel Dieu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Caffeine

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Psychomotor vigilance test Speed
Speed at the Psychomotor vigilance test test

Secondary Outcome Measures

Cognitive performance
Number of errors at executive performance test
Force -velocity
Power at the force-velocity test

Full Information

First Posted
February 25, 2019
Last Updated
August 25, 2021
Sponsor
Institut de Recherche Biomedicale des Armees
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1. Study Identification

Unique Protocol Identification Number
NCT03859882
Brief Title
Protocol PERCAF 2018
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2018 (Actual)
Primary Completion Date
September 3, 2018 (Actual)
Study Completion Date
June 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherche Biomedicale des Armees

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Caffeine, Polymorphism
Keywords
sleep deprivation, cognition, attention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caffeine
Arm Type
Experimental
Arm Description
Caffeine 5 mg/kg/day in 2 administration (08:00 and 14:00) per day
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
in 2 administration (08:00 and 14:00) per day
Intervention Type
Other
Intervention Name(s)
Sleep deprivation
Intervention Description
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 Outcome Measure Information:
Title
Psychomotor vigilance test Speed
Description
Speed at the Psychomotor vigilance test test
Time Frame
Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking
Secondary Outcome Measure Information:
Title
Cognitive performance
Description
Number of errors at executive performance test
Time Frame
Change from Baseline at day 2 after 25 hours awaking
Title
Force -velocity
Description
Power at the force-velocity test
Time Frame
Change from Baseline at day 2 after 32 hours awaking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy subject Exclusion Criteria: Treatment History of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease Nonvoluntary Pregnancy
Facility Information:
Facility Name
Institut de recherche biomedical des armées
City
Brétigny-sur-Orge
Country
France
Facility Name
Hotel Dieu
City
Paris
ZIP/Postal Code
75004
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34685481
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.
Results Reference
derived
PubMed Identifier
33920292
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.
Results Reference
derived

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Protocol PERCAF 2018

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