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Training in Hypoxia to Prevent Acute Mountain Sickness

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886912
First Posted: April 23, 2009
Last Update Posted: June 25, 2010
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.
Information provided by:
Heidelberg University
  Purpose
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 Intervention
Acute Mountain Sickness Healthy Other: hypoxia Other: normoxia

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

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

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

Estimated Enrollment: 50
Study Start Date: June 2008
Estimated Study Completion Date: October 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • any diseases
  • previous exposure to altitudes higher than 2000m (last 6 weeks)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00886912


Contacts
Contact: Kai Schommer, MD +496221568256 kai.schommer@med.uni-heidelberg.de
Contact: Peter Baertsch, MD +496221568101 peter_baertsch@med.uni-heidelberg.de

Locations
Germany
Departement of Sports Medicine, University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Kai Schommer, MD    +49 (0)6221 568256    kai.schommer@med.uni-heidelberg.de   
Contact: Peter Bärtsch, MD    +49 (0)6221 268101    peter.baertsch@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Kai Schommer, MD Departement of Sports Medicine, University of Heidelberg
  More Information

Additional Information:
Responsible Party: Medical Clinic, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00886912     History of Changes
Other Study ID Numbers: S-160/2008
First Submitted: April 21, 2009
First Posted: April 23, 2009
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