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

Effect of High Altitude Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738307
• Other study ID #: REB15 - 2709_MOD2
• Status: Completed
• Phase: N/A
• First received: April 4, 2016
• Last updated: April 23, 2018
• Start date: March 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Altitude Sickness
• Effect of High Altitude

Intervention

Other:
• Altitude exposure
Acute high altitude exposure followed by 8 day acclimatization and re-exposure for 8 days after 6 days at low altitude

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Marc Poulin	University of Zurich

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	Change in oxidative stress measured by venous blood sampling	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)