Hypnotic Intake and Motor and Cognitive Performances at High Altitude

NCT02778659 | Completed

• 1 other identifier: CHAM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Physiology

Outcome Measures

Primary Outcomes (1)

• Cognitive performance assessed using Simon cognitive test

  Simon cognitive test

  4 hours after drug/placebo intake

Study Arms (4)

Zolpidem Normoxia

EXPERIMENTAL

Acute zolpidem intake at sea level

Drug: Zolpidem

Placebo Normoxia

SHAM COMPARATOR

Acute placebo intake at sea level

Drug: Placebo

Zolpidem Hypoxia

EXPERIMENTAL

Acute zolpidem intake at high altitude

Drug: Zolpidem

Placebo Hypoxia

SHAM COMPARATOR

Acute placebo intake at high altitude

Drug: Placebo

Interventions

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.

Zolpidem Hypoxia; Zolpidem Normoxia

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.

Placebo Hypoxia; Placebo Normoxia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No sojourn above 2500 m during the past 2 months
• Coffee intake \< 3 cups per day
• Non-smoker

You may not qualify if:

• Respiratory, cardiovascular, metabolic or neuromuscular diseases
• Psychiatric disorders
• Use of hypnotics within the past year
• Dependence syndrome (alcool, drugs, etc)
• Severe insomnia or somnolence

Sponsors & Collaborators

• Centre d'Expertise sur l'Altitude EXALT: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, Auvergne-Rhône-Alpes, 38043, France

Location

MeSH Terms

Interventions

Zolpidem

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pierre Bouzat, MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 20, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)