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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:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00886912
First received: April 21, 2009
Last updated: June 24, 2010
Last verified: April 2009
  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 Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886912

Locations
Germany
Departement of Sports Medicine, University of Heidelberg
Heidelberg, Germany, 69120
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 
Study First Received: April 21, 2009
Last Updated: June 24, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
mountain sickness

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

ClinicalTrials.gov processed this record on December 02, 2016