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

Primary Purpose

Effect of High Altitude

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
altitude exposure
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Effect of High Altitude focused on measuring High altitude, Cerebral autoregulation, Transfer function analysis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Zurich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Altitude exposure

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 1, 2016
Last Updated
January 15, 2019
Sponsor
University of Zurich
Collaborators
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT02829255
Brief Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Cerebral Autoregulation in Lowlanders
Official Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Cerebral Autoregulation in Lowlanders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 9, 2016 (Actual)
Primary Completion Date
May 4, 2016 (Actual)
Study Completion Date
May 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of High Altitude
Keywords
High altitude, Cerebral autoregulation, Transfer function analysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Altitude exposure
Arm Type
Experimental
Arm Description
Acute high altitude exposure followed by 8 day acclimatization and reexposure for 8 days after 6 days at low altitude
Intervention Type
Other
Intervention Name(s)
altitude exposure
Intervention Description
altitude exposure
Primary Outcome Measure Information:
Title
Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.
Description
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
Time Frame
day 1; day 2 first cycle
Secondary Outcome Measure Information:
Title
Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.
Description
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.
Time Frame
day 1; day 7 first cycle
Title
Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.
Description
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.
Time Frame
day 2; day 7 second cycle
Title
Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.
Description
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.
Time Frame
day 2 first cycle; day 2 second cycle
Title
Coherence between middle cerebral artery blood flow velocity and systemic blood pressure as measure of cerebral autoregulation.
Description
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.
Time Frame
day 7 first cycle; day 7 second cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University of Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
University of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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