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Trial record 82 of 121 for:    ZOLPIDEM AND Central Nervous System Depressants

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

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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

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.

Condition or disease Intervention/treatment Phase
Physiology Drug: Zolpidem Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Acute Hypnotic Intake Before a Night at High Altitude on Cognitive and Motor Performances
Study Start Date : May 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

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Arm Intervention/treatment
Experimental: Zolpidem Normoxia
Acute zolpidem intake at sea level
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.

Sham Comparator: Placebo Normoxia
Acute placebo intake at sea level
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.

Experimental: Zolpidem Hypoxia
Acute zolpidem intake at high altitude
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.

Sham Comparator: Placebo Hypoxia
Acute placebo intake at high altitude
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.




Primary Outcome Measures :
  1. Cognitive performance assessed using Simon cognitive test [ Time Frame: 4 hours after drug/placebo intake ]
    Simon cognitive test



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02778659


Locations
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France
Grenoble University Hospital
Grenoble, Rhone Alpes, France, 38043
Sponsors and Collaborators
Centre d’Expertise sur l’Altitude EXALT
Investigators
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Principal Investigator: Pierre Bouzat, MD PhD University Hospital, Grenoble

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Responsible Party: Centre d’Expertise sur l’Altitude EXALT
ClinicalTrials.gov Identifier: NCT02778659     History of Changes
Other Study ID Numbers: CHAM
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Zolpidem
Hypnotics and Sedatives
Sleep Aids, Pharmaceutical
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action