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Prevention of Acute Mountain Sickness by Intermittent Hypoxia

This study has been completed.

Sponsored by: University of Heidelberg
Information provided by: University of Heidelberg
ClinicalTrials.gov Identifier: NCT00559832
  Purpose

Acclimatization by mountaineering prior to high altitude sojourns have shown to be effective in prevention of acute mountain sickness (AMS).

The aim of this study is to investigate whether intermittent exposure to normobaric hypoxia during sleep is also effective to prevent AMS.


Condition Intervention
Acute Mountain Sickness
Other: Hypoxic Exposure

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:   Prevention of Acute Mountain Sickness by Sleeping at Simulated Altitude (Normobaric Hypoxia)

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • incidence of acute mountain sickness [ Time Frame: during one night at 4500 m ]

Secondary Outcome Measures:
  • Sleep quality [ Time Frame: during one night at altitude ]
  • ventilatory acclimatization [ Time Frame: during one night at altitude ]

Enrollment:   75
Study Start Date:   March 2006
Study Completion Date:   July 2007

Arms Assigned Interventions
Normoxia: No Intervention
Sleeping in normoxia for 14 nights prior to one night at 4500 m
Hypoxia: Experimental
Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m
Other: Hypoxic Exposure
Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • Altitude exposure above 2000 m 8 weeks prior or during the study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559832

Locations
Germany
Sports Medicine, University Hospital    
      Heidelberg, Germany, 69120

Sponsors and Collaborators
University of Heidelberg

Investigators
Principal Investigator:     Christoph Dehnert, MD     University Hospital Heidelberg    
  More Information


Study ID Numbers:   039/2006
First Received:   November 15, 2007
Last Updated:   November 15, 2007
ClinicalTrials.gov Identifier:   NCT00559832
Health Authority:   Germany: Ethics Commission

Keywords provided by University of Heidelberg:
acute mountain sickness  
intermittent hypoxia  
acclimatization  

Study placed in the following topic categories:
Signs and Symptoms
Altitude Sickness
Respiratory Tract Diseases
Acute mountain sickness
Respiration Disorders
Signs and Symptoms, Respiratory
Anoxia

ClinicalTrials.gov processed this record on October 10, 2008




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