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Protocol PERCAF 2018 (PERCAF)

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ClinicalTrials.gov Identifier: NCT03859882
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Recherche Biomedicale des Armees

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Caffeine Polymorphism Other: Sleep deprivation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2, 2018
Actual Primary Completion Date : September 3, 2018
Estimated Study Completion Date : June 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Caffeine
Caffeine 5 mg/kg/day in 2 administration (08:00 and 14:00) per day
 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).
Placebo Comparator: placebo
in 2 administration (08:00 and 14:00) per day
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Psychomotor vigilance test Speed [ Time Frame: Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking ]
    Speed at the Psychomotor vigilance test test


Secondary Outcome Measures :
  1. Cognitive performance [ Time Frame: Change from Baseline at day 2 after 25 hours awaking ]
    Number of errors at executive performance test

  2. Force -velocity [ Time Frame: Change from Baseline at day 2 after 32 hours awaking ]
    Power at the force-velocity test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subject

Exclusion Criteria:

  • Treatment
  • History of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease
  • Nonvoluntary
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859882


Contacts
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Contact: Fabien SAUVET, MD 0033 6 62 20 9331 fabien.sauvet@gmail.com
Contact: Mégane ERBLANG, MSC 0033 6 62 20 9331 megane.erblang@gmail.com

Locations
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France
Institut de recherche biomedical des armées Enrolling by invitation
Brétigny-sur-Orge, France
Hotel Dieu Recruiting
Paris, France, 75004
Contact: Damien Leger, Pr    00330112654543    damien.leger@aphp.com   
Sub-Investigator: Damien LEGER         
Sponsors and Collaborators
Institut de Recherche Biomedicale des Armees
More Information
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Responsible Party: Institut de Recherche Biomedicale des Armees
ClinicalTrials.gov Identifier: NCT03859882    
Other Study ID Numbers: Protocol PERCAF 2018
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Recherche Biomedicale des Armees:
sleep deprivation
cognition
attention
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
 Nervous System Diseases
Neurologic Manifestations
Mental Disorders