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Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance in Lowlanders

Primary Purpose

Effect of High Altitude

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
altitude exposure
Sponsored by
Marc Poulin
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, cognition, sleep

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • born, raised and currently living <1300m
  • No overnight stays at altitudes >1500m 4 weeks before the study

Exclusion Criteria:

  • previous altitude intolerance <3000m
  • pregnancy
  • health impairment, which requires regular treatment

Sites / Locations

  • University of Calgary

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 re-exposure for 8 days after 6 days at low altitude.

Outcomes

Primary Outcome Measures

Sustained attention measured by a visual pychomotor vigilance test (PVT)
Change in psychomotor response speed across two cycles of altitude exposure, comparing 5050m to 520m.

Secondary Outcome Measures

Indices of sleep quality measured by actigraphy (total sleep time, sleep efficiency, sleep latency

Full Information

First Posted
April 3, 2016
Last Updated
April 23, 2018
Sponsor
Marc Poulin
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02731456
Brief Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance in Lowlanders
Official Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance and Sleep Quality in Lowlanders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marc Poulin
Collaborators
University of Zurich

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 psychomotor vigilance to measure sustained attention.
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 (2 h flight) and by bus (2 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 7 nights and they will spend the days (6 total; 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 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 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, cognition, sleep

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Altitude exposure
Arm Type
Experimental
Arm Description
Acute high altitude exposure followed by 8 day acclimatization and re-exposure 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
Sustained attention measured by a visual pychomotor vigilance test (PVT)
Description
Change in psychomotor response speed across two cycles of altitude exposure, comparing 5050m to 520m.
Time Frame
Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7
Secondary Outcome Measure Information:
Title
Indices of sleep quality measured by actigraphy (total sleep time, sleep efficiency, sleep latency
Time Frame
Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: born, raised and currently living <1300m No overnight stays at altitudes >1500m 4 weeks before the study Exclusion Criteria: previous altitude intolerance <3000m pregnancy health impairment, which requires regular treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc J Poulin, PhD, DPhil
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance in Lowlanders

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