National Center of Cardiology and Internal Medicine
Bishkek, 720040, Kyrgyzstan
NCT Number: NCT03536520
Randomized, placebo controlled trial evaluating the effect of acetazolamide on visuo-motor learning performance in lowlanders older than 40 years travelling from 760 m to 3'100 m.
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Notify Me40 year–75 year
All sexes
Interventional
Phase 4
Bishkek, 720040, Kyrgyzstan
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide intake on visuo-motor learning performance in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.
An interim analysis will be carried out when 80 participants will have completed the study or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
Time frame: Day 2 at 760m and 3'100m
Difference in altitude-induced change in directional error evaluated by the motor task manager during 760 m baseline measurements and measurements at 3100 m between acetazolamide and placebo group
Time frame: Day 1 and 2 at 760 m and at 3'100m
Altitude-induced change in visuomotor learning performance assessed at 760 m baseline and at 3100 m in the placebo and in the acetazolamide group
Time frame: Day 1 and 2 at 760 m and at 3'100m
Difference in altitude-induced change of arterial oxygen saturation from 760 m baseline measurement to measurement at 3100 m between acetazolamide and placebo group, measured by pulse oxymetry
University of Zurich
Other
Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
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