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Completed

NCT Number: NCT02738307

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

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

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Key information

Conditions

Effect of High Altitude Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Altitude exposure

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Marc Poulin

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2016
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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