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

Centre d'Expertise sur l'Altitude EXALT

Status: Completed

Conditions: Physiology

Treatments: Drug: Placebo; Drug: Zolpidem

Study type: Interventional

Funder types: Other

Identifiers

NCT02778659

CHAM

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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22 participants in 4 patient groups

Zolpidem Normoxia

Experimental group

Description:

Acute zolpidem intake at sea level

Treatment:

Drug: Zolpidem

Placebo Normoxia

Sham Comparator group

Description:

Acute placebo intake at sea level

Treatment:

Drug: Placebo

Zolpidem Hypoxia

Experimental group

Description:

Acute zolpidem intake at high altitude

Treatment:

Drug: Zolpidem

Placebo Hypoxia

Sham Comparator group

Description:

Acute placebo intake at high altitude

Treatment:

Drug: Placebo