Hypnotic Intake and Motor and Cognitive Performances at High Altitude

Physiology Clinical Trial

— CHAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778659
• Other study ID #: CHAM
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: January 4, 2018
• Start date: May 2016
• Est. completion date: October 2017

Study information

• Verified date: January 2018
• Source: Centre d’Expertise sur l’Altitude EXALT
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Physiology

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Expertise sur l’Altitude EXALT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance assessed using Simon cognitive test	Simon cognitive test	4 hours after drug/placebo intake