Hypnotic Intake and Motor and Cognitive Performances at High Altitude

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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Key information

Conditions

Physiology

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble University Hospital

Grenoble, Auvergne-Rhône-Alpes, 38043, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zolpidem

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

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.

Primary outcomes

Cognitive performance assessed using Simon cognitive test

Time frame: 4 hours after drug/placebo intake

Simon cognitive test

Sponsors and collaborators

Lead sponsor

Centre d'Expertise sur l'Altitude EXALT

Other

Registry information

Official study title

The Effect of Acute Hypnotic Intake Before a Night at High Altitude on Cognitive and Motor Performances

Acronym: CHAM

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: May 20, 2016
Registry last updated: Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed