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

University of Zurich78 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

ACETAZOLAMIDE oral capsuleDRUG

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

Placebo oral capsuleDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

National Center of Cardiology and Internal Medicine

Bishkek, Kyrgyzstan

Outcomes

Primary Outcomes

visuomotor learning performance, drug effect

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

Time frame: Day 2 at 760m and 3200m

visuomotor learning performance, altitude effect

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

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

Secondary Outcomes

arterial oxygen saturation

Difference in altitude-induced change of arterial oxygen saturation between acetazolamide and placebo group, measured by pulse oxymetry

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

Data from ClinicalTrials.gov

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