CHAM: Hypnotic Intake and Motor and Cognitive Performances at High Altitude

• Sponsor: Centre d'Expertise sur l'Altitude EXALT (Other)
• Overall Status: Completed
• CT.gov ID: NCT02778659
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 4
• Duration (Months): 17
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physiology	Drug: Zolpidem; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Effect of Acute Hypnotic Intake Before a Night at High Altitude on Cognitive and Motor Performances
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zolpidem Normoxia Acute zolpidem intake at sea level	Drug: 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.
Sham Comparator: Placebo Normoxia Acute placebo intake at sea level	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.
Experimental: Zolpidem Hypoxia Acute zolpidem intake at high altitude	Drug: 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.
Sham Comparator: Placebo Hypoxia Acute placebo intake at high altitude	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.

Outcome Measures

Primary Outcome Measures

1. Cognitive performance assessed using Simon cognitive test [4 hours after drug/placebo intake]

   Simon cognitive test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grenoble University Hospital	Grenoble	Rhone Alpes	France	38043

Sponsors and Collaborators

• Centre d'Expertise sur l'Altitude EXALT

Investigators

• Principal Investigator: Pierre Bouzat, MD PhD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre d'Expertise sur l'Altitude EXALT
• ClinicalTrials.gov Identifier: NCT02778659
• Other Study ID Numbers: CHAM
• First Posted: May 20, 2016
• Last Update Posted: Jan 5, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Zolpidem

Study Results

No Results Posted as of Jan 5, 2018