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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02730182
Other study ID # REB15-2709_V3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2016
Est. completion date May 4, 2016

Study information

Verified date January 2019
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on postural control


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date May 4, 2016
Est. primary completion date May 4, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
altitude exposure
altitude exposure

Locations

Country Name City State
Switzerland University of Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center of pressure path length measured by Wii-balance board 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 Cerebral tissue oxygen saturation measured by near infrared spectroscopy 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
Secondary Postural stability measured by sharpened Romberg-test and heel-to-toe walk 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
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