Back to resultsPrevention of Acute Mountain Sickness by Intermittent Hypoxia
Primary Purpose
Acute Mountain Sickness
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hypoxic Exposure
Sponsored by
About this trial
This is an interventional prevention trial for Acute Mountain Sickness focused on measuring acute mountain sickness, intermittent hypoxia, acclimatization
Eligibility Criteria
Inclusion Criteria:
- healthy
Exclusion Criteria:
- Altitude exposure above 2000 m 8 weeks prior or during the study
Sites / Locations
- Sports Medicine, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Normoxia
Hypoxia
Arm Description
Sleeping in normoxia for 14 nights prior to one night at 4500 m
Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m
Outcomes
Primary Outcome Measures
incidence of acute mountain sickness
Secondary Outcome Measures
Sleep quality
ventilatory acclimatization
Full Information
NCT ID
NCT00559832
First Posted
November 15, 2007
Last Updated
November 15, 2007
Sponsor
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT00559832
Brief Title
Prevention of Acute Mountain Sickness by Intermittent Hypoxia
Official Title
Prevention of Acute Mountain Sickness by Sleeping at Simulated Altitude (Normobaric Hypoxia)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness
Keywords
acute mountain sickness, intermittent hypoxia, acclimatization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normoxia
Arm Type
No Intervention
Arm Description
Sleeping in normoxia for 14 nights prior to one night at 4500 m
Arm Title
Hypoxia
Arm Type
Experimental
Arm Description
Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m
Intervention Type
Other
Intervention Name(s)
Hypoxic Exposure
Intervention Description
Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m
Primary Outcome Measure Information:
Title
incidence of acute mountain sickness
Time Frame
during one night at 4500 m
Secondary Outcome Measure Information:
Title
Sleep quality
Time Frame
during one night at altitude
Title
ventilatory acclimatization
Time Frame
during one night at altitude
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy
Exclusion Criteria:
Altitude exposure above 2000 m 8 weeks prior or during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Dehnert, MD
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sports Medicine, University Hospital
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Prevention of Acute Mountain Sickness by Intermittent Hypoxia
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