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

C

Centre d'Expertise sur l'Altitude EXALT

Status

Completed

Conditions

Physiology

Treatments

Drug: Placebo
Drug: Zolpidem

Study type

Interventional

Funder types

Other

Identifiers

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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