Prevention of Acute Mountain Sickness by Intermittent Hypoxia

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00559832
First received: November 15, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Prevention of Acute Mountain Sickness by Sleeping at Simulated Altitude (Normobaric Hypoxia)

Further study details as provided by Heidelberg University:

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
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

  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
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: NCT00559832

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on July 24, 2014