Effect of High Altitude Exposure, Acclimatization and Re-exposure on Cerebral Autoregulation in Lowlanders

Effect of High Altitude Clinical Trial

Official title:

Effect of High Altitude Exposure, Acclimatization and Re-exposure on Cerebral Autoregulation in Lowlanders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829255
• Other study ID #: REB15-2709_V4
• Status: Completed
• Phase: N/A
• 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
• 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 cerebral autoregulation

Description:

Baseline measurements 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 ALMA base camp 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

Related Conditions & MeSH terms

• Altitude Sickness
• Effect of High Altitude

Intervention

Other:
• altitude exposure
altitude exposure

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University of Calgary

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.	Change in magnitude of the coefficient of coherence between blood flow velocity in the middle cerebral artery measured by transcranial ultrasound Doppler and systemic blood pressure at day 2 (5050 m) vs. day 1 (520 m) of the first cycle	day 1; day 2 first cycle
Secondary	Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.	Change in magnitude of the coefficient of coherence between blood flow velocity in the middle cerebral artery measured by transcranial ultrasound Doppler and systemic blood pressure at day 7 (5050 m) vs. day 1 (520 m) of the first cycle.	day 1; day 7 first cycle
Secondary	Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.	Change in magnitude of the coefficient of coherence between blood flow velocity in the middle cerebral artery measured by transcranial ultrasound Doppler and systemic blood pressure at day 7 (5050 m) vs. day 2 (5050 m) of the second cycle.	day 2; day 7 second cycle
Secondary	Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.	Change in magnitude of the coefficient of coherence between blood flow velocity in the middle cerebral artery measured by transcranial ultrasound Doppler and systemic blood pressure at day 2 (5050 m) second cycle vs. day 2 (5050 m) of the first cycle.	day 2 first cycle; day 2 second cycle
Secondary	Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.	Change in magnitude of the coefficient of coherence between blood flow velocity in the middle cerebral artery measured by transcranial ultrasound Doppler and systemic blood pressure at day 7 (5050 m) second cycle vs. day 7 (5050 m) of the first cycle.	day 7 first cycle; day 7 second cycle