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Hypnotic Intake and Motor and Cognitive Performances at High Altitude (CHAM)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02778659
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Centre d’Expertise sur l’Altitude EXALT

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE May 20, 2016
Last Update Posted Date January 5, 2018
Study Start Date  ICMJE May 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2016)
Cognitive performance assessed using Simon cognitive test [ Time Frame: 4 hours after drug/placebo intake ]
Simon cognitive test
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02778659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypnotic Intake and Motor and Cognitive Performances at High Altitude
Official Title  ICMJE The Effect of Acute Hypnotic Intake Before a Night at High Altitude on Cognitive and Motor Performances
Brief Summary This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep, cognitive and motor performances and on acute mountain sickness symptoms at high altitude. Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms, cognitive and motor performances will be assessed to determine potential residual effects of Zolpidem within such conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Physiology
Intervention  ICMJE
  • Drug: Zolpidem
    The hypnotic will be administrated orally at 22:00 in the evening before a sleep recording and an early wake-up at 01:00 for cognitive and motor assessment.
  • Drug: Placebo
    The placebo will be administrated orally at 22:00 in the evening before a sleep recording and an early wake-up at 01:00 for cognitive and motor assessment.
Study Arms  ICMJE
  • Experimental: Zolpidem Normoxia
    Acute zolpidem intake at sea level
    Intervention: Drug: Zolpidem
  • Sham Comparator: Placebo Normoxia
    Acute placebo intake at sea level
    Intervention: Drug: Placebo
  • Experimental: Zolpidem Hypoxia
    Acute zolpidem intake at high altitude
    Intervention: Drug: Zolpidem
  • Sham Comparator: Placebo Hypoxia
    Acute placebo intake at high altitude
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2016)
24
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • No sojourn above 2500 m during the past 2 months
  • Coffee intake < 3 cups per day
  • Non-smoker

Exclusion Criteria:

  • Respiratory, cardiovascular, metabolic or neuromuscular diseases
  • Psychiatric disorders
  • Use of hypnotics within the past year
  • Dependence syndrome (alcool, drugs, etc)
  • Severe insomnia or somnolence
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02778659
Other Study ID Numbers  ICMJE CHAM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre d’Expertise sur l’Altitude EXALT
Study Sponsor  ICMJE Centre d’Expertise sur l’Altitude EXALT
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre Bouzat, MD PhD University Hospital, Grenoble
PRS Account Centre d’Expertise sur l’Altitude EXALT
Verification Date January 2018

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