Training in Hypoxia to Prevent Acute Mountain Sickness

June 24, 2010 updated by: Heidelberg University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hypoxia
training in simulated altitude
Other: hypoxia
training in simulated altitude in a hypoxic chamber (normobaric hypoxia)
Placebo Comparator: Normoxia
training under normoxic conditions
Other: normoxia
training under normoxic conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of acute mountain sickness
Time Frame: after 20 hours at 4559m
after 20 hours at 4559m

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity of acute mountain sickness
Time Frame: after 20 hours at 4559m
after 20 hours at 4559m

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Kai Schommer, MD, Departement of Sports Medicine, University of Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Estimate)

June 25, 2010

Last Update Submitted That Met QC Criteria

June 24, 2010

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-160/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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