Effect of High Altitude Exposure, Acclimatization and Re-exposure on Sustained Attention in Lowlanders
Primary Purpose
Effect of High Altitude
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Altitude exposure
Sponsored by
About this trial
This is an interventional prevention trial for Effect of High Altitude focused on measuring High Altitude, Attention, Cognitive Function, Acclimatization, Sleep
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
Sites / Locations
- University of Calgary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
altitude exposure
Arm Description
Altitude Exposure Acute high altitude exposure followed by 8 day acclimatization and reexposure for 8 days after 6 days at low altitude
Outcomes
Primary Outcome Measures
Change in global cognitive function assessed by neuropsychological test battery
Change in global cognition measured across two cycles of altitude exposure, comparing 5050m to 520m
Secondary Outcome Measures
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
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
Change in oxidative stress measured by venous blood sampling
Change in oxidative stress measured before and after high altitude exposure
Full Information
NCT ID
NCT02738307
First Posted
April 4, 2016
Last Updated
April 23, 2018
Sponsor
Marc Poulin
Collaborators
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT02738307
Brief Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Sustained Attention in Lowlanders
Official Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Global Cognitive Function
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 global cognitive function.
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.
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, Attention, Cognitive Function, Acclimatization, 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
Altitude Exposure 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
Acute high altitude exposure followed by 8 day acclimatization and re-exposure for 8 days after 6 days at low altitude
Primary Outcome Measure Information:
Title
Change in global cognitive function assessed by neuropsychological test battery
Description
Change in global cognition measured across two cycles of altitude exposure, comparing 5050m to 520m
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)
Secondary Outcome Measure Information:
Title
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
Description
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
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)
Title
Change in oxidative stress measured by venous blood sampling
Description
Change in oxidative stress measured before and after high altitude exposure
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)
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 <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
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Effect of High Altitude Exposure, Acclimatization and Re-exposure on Sustained Attention in Lowlanders
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