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Completed

NCT Number: NCT03536520

Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude

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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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men and women, age 40-75 yrs, without any disease and need of medication.
  • Born, raised and currently living at low altitude (<800m).
  • Written informed consent.
  • Kyrgyz ethnicity

Exclusion criteria

  • Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
  • Any condition that may interfere with protocol compliance including current heavy smoking (>20 cigarettes per day or >20 pack-years with active smoking during the last 10 years), regular use of alcohol.
  • Allergy to acetazolamide and other sulfonamides.

Treatment and study plan

ACETAZOLAMIDE oral capsule

Drug

Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m

Placebo oral capsule

Drug

Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m

Primary outcomes

  1. 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 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

Secondary outcomes

  1. Altitude-induced change in visuomotor learning performance assessed at 760 m baseline and at 3100 m

    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

  2. Change in arterial oxygen saturation

    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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Registry information

Official study title

Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 24, 2018
Registry last updated
Oct 12, 2021

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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