Effect of High Altitude Exposure, Acclimatization and Re-exposure on Sustained Attention in Lowlanders
1 other identifier
interventional
18
1 country
1
Brief Summary
Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on global cognitive function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 4, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedApril 25, 2018
April 1, 2018
1.8 years
April 4, 2016
April 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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 Outcomes (2)
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
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
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)
Study Arms (1)
altitude exposure
EXPERIMENTALAltitude Exposure Acute high altitude exposure followed by 8 day acclimatization and reexposure for 8 days after 6 days at low altitude
Interventions
Acute high altitude exposure followed by 8 day acclimatization and re-exposure for 8 days after 6 days at low altitude
Eligibility Criteria
You may qualify if:
- born, raised and currently living \<1300m
- No overnight stays at altitudes \>1500m 4 weeks before the study
You may not qualify if:
- previous altitude intolerance \<3000m
- pregnancy
- health impairment, which requires regular treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marc Poulinlead
- University of Zurichcollaborator
Study Sites (1)
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc J Poulin, PhD, DPhil
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 4, 2016
First Posted
April 14, 2016
Study Start
March 1, 2016
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
April 25, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share