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NCT00559832 Clinical Trial

Prevention of Acute Mountain Sickness by Intermittent Hypoxia

Acute Mountain Sickness Clinical Trial

Official title:
Prevention of Acute Mountain Sickness by Sleeping at Simulated Altitude (Normobaric Hypoxia)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00559832
Other study ID # 039/2006
Secondary ID
Status Completed
Phase N/A
First received November 15, 2007
Last updated November 15, 2007
Start date March 2006
Est. completion date July 2007

Study information
Verified date November 2007
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Acclimatization by mountaineering prior to high altitude sojourns have shown to be effective in prevention of acute mountain sickness (AMS).

The aim of this study is to investigate whether intermittent exposure to normobaric hypoxia during sleep is also effective to prevent AMS.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- healthy

Exclusion Criteria:

- Altitude exposure above 2000 m 8 weeks prior or during the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Hypoxic Exposure
Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m

Locations
Country Name City State
Germany Sports Medicine, University Hospital Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of acute mountain sickness during one night at 4500 m
Secondary Sleep quality during one night at altitude
Secondary ventilatory acclimatization during one night at altitude
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