Hypnotic Intake and Motor and Cognitive Performances at High Altitude

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Physiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Zolpidem Normoxia

Acute zolpidem intake at sea level

Group Type EXPERIMENTAL

Zolpidem

Intervention Type DRUG

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.

Placebo Normoxia

Acute placebo intake at sea level

Group Type SHAM_COMPARATOR

Placebo

Intervention Type DRUG

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.

Zolpidem Hypoxia

Acute zolpidem intake at high altitude

Group Type EXPERIMENTAL

Zolpidem

Intervention Type DRUG

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.

Placebo Hypoxia

Acute placebo intake at high altitude

Group Type SHAM_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes