- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02730182
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Postural Control in Lowlanders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Baseline measurements including the assessment of the center of pressure during 30s, the cerebral oxygen saturation and a sharpened Romberg test will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the base camp of the Atacama Large Millimeter/Submillimeter Array (ALMA) telescope station located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 8 nights and they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 8 day altitude sojourn participants will return to the Santiago area (520 m) for a 6 day recovery period.
A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Zurich, Switzerland, 8091
- University of Zurich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- born, raised and currently living <800m
- No overnight stay at altitudes >1500 m 4 weeks before the study
Exclusion Criteria:
- Previous altitude intolerance to altitude <3000 m
- Pregnancy
- Health impairment, which requires regular treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Altitude exposure
Acute high altitude exposure followed by 8 day acclimatization and reexposure for 8 days after 6 days at low altitude
|
altitude exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center of pressure path length measured by Wii-balance board
Time Frame: Low altitude sojourn at 520 m; first sojourn at 5050 m Day 2, 7; second sojourn at 5050 m Day 2, 7
|
Changes in center of pressure path length during the 2 sojourns at 5050 m and compared to lowland.
|
Low altitude sojourn at 520 m; first sojourn at 5050 m Day 2, 7; second sojourn at 5050 m Day 2, 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral tissue oxygen saturation measured by near infrared spectroscopy
Time Frame: Low altitude sojourn at 520 m; first sojourn at 5050 m Day 2, 7; second sojourn at 5050 m Day 2, 7
|
Changes in cerebral oxygen saturation during the 2 sojourns at 5050 m and compared to lowland.
|
Low altitude sojourn at 520 m; first sojourn at 5050 m Day 2, 7; second sojourn at 5050 m Day 2, 7
|
Postural stability measured by sharpened Romberg-test and heel-to-toe walk
Time Frame: Low altitude sojourn at 520 m; first sojourn at 5050 m Day 2, 7; second sojourn at 5050 m Day 2, 7
|
Changes in postural stability during the 2 sojourns at 5050 m and compared to lowland.
|
Low altitude sojourn at 520 m; first sojourn at 5050 m Day 2, 7; second sojourn at 5050 m Day 2, 7
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB15-2709_V3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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