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NCT00886912 Clinical Trial

Training in Hypoxia to Prevent Acute Mountain Sickness

Healthy Clinical Trial

Official title:
Prevention of Acute Mountain Sickness (AMS) by Intermittent Hypoxic Training

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00886912
Other study ID # S-160/2008
Secondary ID
Status Recruiting
Phase N/A
First received April 21, 2009
Last updated June 24, 2010
Start date June 2008
Est. completion date October 2009

Study information
Verified date April 2009
Source Heidelberg University
Contact Kai Schommer, MD
Phone +496221568256
Email kai.schommer@med.uni-heidelberg.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Some studies suggest that high-altitude related illnesses - like acute mountain sickness - could be prevented by acclimatisation, reached at low altitude using training in simulated altitude. The purpose of this study is to determine whether training in hypoxia is suitable to prevent acute mountain sickness.

Description:

In a three week-period, healthy probands undergo 3 times a week a bicycle ergometer training in simulated altitude followed by 1 week passive exposure at simulated low altitude. 5 days after last exposure, a field study starts performing a rapid ascent to the Capanna Regina Margherita (4559m). Acute mountain sickness is assessed by established scoring systems.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date October 2009
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- healthy

- non-smoker

- endurance training min. 2x/week

Exclusion Criteria:

- any diseases

- previous exposure to altitudes higher than 2000m (last 6 weeks)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• hypoxia
training in simulated altitude in a hypoxic chamber (normobaric hypoxia)
• normoxia
training under normoxic conditions

Locations
Country Name City State
Germany Departement of Sports Medicine, University of Heidelberg 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 after 20 hours at 4559m Yes
Secondary Severity of acute mountain sickness after 20 hours at 4559m Yes
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