Effect of High Altitude Exposure, Acclimatization and Re-exposure on Sustained Attention in Lowlanders

April 23, 2018 updated by: Marc Poulin

Effect of High Altitude Exposure, Acclimatization and Re-exposure on Global Cognitive Function

Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on global cognitive function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 be 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.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: altitude exposure
Altitude Exposure Acute high altitude exposure followed by 8 day acclimatization and reexposure for 8 days after 6 days at low altitude
Other: Altitude exposure
Acute high altitude exposure followed by 8 day acclimatization and re-exposure for 8 days after 6 days at low altitude

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in global cognitive function assessed by neuropsychological test battery
Time Frame: Low altitude sojourn at 520m (Baseline); first sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7 (each sojourn cycle = 7 days)
Change in global cognition measured across two cycles of altitude exposure, comparing 5050m to 520m
Low altitude sojourn at 520m (Baseline); first sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7 (each sojourn cycle = 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive subdomains (visual memory, executive function, working memory and planning, attention, semantic/verbal memory, decision-making and response control) assessed by neuropsychological test battery
Time Frame: Low altitude sojourn at 520m (Baseline); first sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7 (each sojourn cycle = 7 days)
Change in cognitive subdomains (visual memory, executive function, working memory and planning, attention, semantic/verbal memory, decision-making and response control) measured across two cycles of altitude exposure, comparing 5050m to 520m
Low altitude sojourn at 520m (Baseline); first sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7 (each sojourn cycle = 7 days)
Change in oxidative stress measured by venous blood sampling
Time Frame: Low altitude sojourn at 520m (Baseline); first sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7 (each sojourn cycle = 7 days)
Change in oxidative stress measured before and after high altitude exposure
Low altitude sojourn at 520m (Baseline); first sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7 (each sojourn cycle = 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marc Poulin

Collaborators

University of Zurich

Investigators

  • Principal Investigator: Marc J Poulin, PhD, DPhil, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 8, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB15 - 2709_MOD2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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