ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Acute Mountain Sickness by Intermittent Hypoxia

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.
ClinicalTrials.gov Identifier: NCT00559832
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : November 16, 2007
Sponsor:
Information provided by:
Heidelberg University

Brief Summary:

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 or disease Intervention/treatment Phase
Acute Mountain Sickness Other: Hypoxic Exposure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Prevention of Acute Mountain Sickness by Sleeping at Simulated Altitude (Normobaric Hypoxia)
Study Start Date : March 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Normoxia
Sleeping in normoxia for 14 nights prior to one night at 4500 m
Experimental: Hypoxia
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



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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

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): NCT00559832


Locations
Germany
Sports Medicine, University Hospital
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Christoph Dehnert, MD University Hospital Heidelberg

ClinicalTrials.gov Identifier: NCT00559832     History of Changes
Other Study ID Numbers: 039/2006
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: November 16, 2007
Last Verified: November 2007

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

Additional relevant MeSH terms:
Hypoxia
Altitude Sickness
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases