Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Protocol PERCAF 2018 (PERCAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE March 1, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE September 2, 2018
Actual Primary Completion Date September 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
  • Cognitive performance [ Time Frame: Change from Baseline at day 2 after 25 hours awaking ]
    Number of errors at executive performance test
  • Force -velocity [ Time Frame: Change from Baseline at day 2 after 32 hours awaking ]
    Power at the force-velocity test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protocol PERCAF 2018
Official Title  ICMJE Polymorphisms and Efficiency of Caffeine on Performances During Total Sleep Deprivation un Healthy Subject. Multicentric, Versus Placebo, Randomised, Cross Over, Double Blind Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep
  • Caffeine
  • Polymorphism
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Experimental: Caffeine
    Caffeine 5 mg/kg/day in 2 administration (08:00 and 14:00) per day
    Intervention: Other: Sleep deprivation
  • Placebo Comparator: placebo
    in 2 administration (08:00 and 14:00) per day
    Intervention: Other: Sleep deprivation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2019)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 26, 2019
Actual Primary Completion Date September 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy subject

Exclusion Criteria:

  • Treatment
  • History of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease
  • Nonvoluntary
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03859882
Other Study ID Numbers  ICMJE Protocol PERCAF 2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut de Recherche Biomedicale des Armees
Study Sponsor  ICMJE Institut de Recherche Biomedicale des Armees
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut de Recherche Biomedicale des Armees
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP