Training in Hypoxia to Prevent Acute Mountain Sickness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00886912
Recruitment Status : Unknown
Verified April 2009 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : April 23, 2009
Last Update Posted : June 25, 2010
Information provided by:
Heidelberg University

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Mountain Sickness Healthy Other: hypoxia Other: normoxia Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Acute Mountain Sickness (AMS) by Intermittent Hypoxic Training
Study Start Date : June 2008
Actual Primary Completion Date : August 2008
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Incidence of acute mountain sickness [ Time Frame: after 20 hours at 4559m ]

Secondary Outcome Measures :
  1. Severity of acute mountain sickness [ Time Frame: after 20 hours at 4559m ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy
  • non-smoker
  • endurance training min. 2x/week

Exclusion Criteria:

  • any diseases
  • previous exposure to altitudes higher than 2000m (last 6 weeks)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00886912

Contact: Kai Schommer, MD +496221568256
Contact: Peter Baertsch, MD +496221568101

Departement of Sports Medicine, University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Kai Schommer, MD    +49 (0)6221 568256   
Contact: Peter Bärtsch, MD    +49 (0)6221 268101   
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Kai Schommer, MD Departement of Sports Medicine, University of Heidelberg

Additional Information:
Responsible Party: Medical Clinic, University of Heidelberg Identifier: NCT00886912     History of Changes
Other Study ID Numbers: S-160/2008
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: June 25, 2010
Last Verified: April 2009

Keywords provided by Heidelberg University:
mountain sickness

Additional relevant MeSH terms:
Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases