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

NCT ID: NCT02829255

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-09
• Study Completion Date: 2016-05-04

Brief Summary

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

Detailed 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.

Conditions

Effect of High Altitude

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Altitude exposure

Acute high altitude exposure followed by 8 day acclimatization and reexposure for 8 days after 6 days at low altitude

Group Type: EXPERIMENTAL

altitude exposure

Intervention Type: OTHER

altitude exposure

Interventions

altitude exposure

altitude exposure

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konrad E Bloch, MD

Role: STUDY_CHAIR

University of Zurich

Locations

University of Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

REB15-2709_V4

Identifier Type: -

Identifier Source: org_study_id