Skip to main content
OpenTrials
Completed

NCT Number: NCT03165890

Effect of Acetazolamide on Cognition in Patients With Respiratory Disease at Altitude

Randomized, placebo controlled trial evaluating the effect of acetazolamide on cognition in lowlanders with chronic obstructive pulmonary disease travelling from 760 m to 3200 m.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 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 (375 mg per day) vs. placebo on visuomotor learning performance at altitude (Tuja Ashu, 3200 m). Randomization to acetazolamide or placebo will be carried out after baseline measurements in Bishkek (760 m).

Visuomotor learning performance will be tested by Motor Task Manager (MTM). The MTM requires the subjects to reach visual targets with a hand-held cursor. During progression of the test, the movement direction from the cursor on the computer screen will increasingly differ from the direction of the hand movement, forcing the unaware subject to implicitly adapt to the imposed cursor rotation. This test assesses a subjects ability to visuomotor adaption, perception and attention. Furthermore, as the task will be performed in the evening and after sleep in the next morning, the investigators will be able to assess overnight improvement of implicit learned skills.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients, age 18-75 yrs.
  • COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
  • Born, raised and currently living at low altitude (<800m).
  • Written informed consent.

Exclusion criteria

  • COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92% at 750 m).
  • Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
  • Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (>20 cigarettes per day)
  • Known renal failure or allergy to acetazolamide and other sulfonamides

Treatment and study plan

ACETAZOLAMIDE oral capsule

Drug

Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m

Placebo oral capsule

Drug

Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m

Primary outcomes

  1. visuomotor learning performance, drug effect

    Time frame: Day 2 at 760m and 3200m

    Difference in altitude-induced change in directional error between acetazolamide and placebo group, measured by the motor task manager

  2. visuomotor learning performance, altitude effect

    Time frame: Day 1 and 2 at 760 m and at 3200m

    Difference in directional error between 760 m and 3200 m altitude in placebo group

Secondary outcomes

  1. arterial oxygen saturation

    Time frame: Day 1 and 2 at 760 m and at 3200m

    Difference in altitude-induced change of arterial oxygen saturation 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 Visuomotor Learning Performance in Patients With Chronic Obstructive Pulmonary Disease at Altitude

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 24, 2017
Registry last updated
May 14, 2019

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.

Published trials that share one or more normalized conditions with this study.