Effect of High Altitude Clinical Trial
Official title:
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Postural Control in Lowlanders
| 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 |
| Verified date | January 2019 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on postural control
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University of Zurich | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| 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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|---|---|---|---|
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