Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude

University of Zurich185 enrolled

Overview

Randomized, placebo controlled trial evaluating the effect of acetazolamide on sleep disordered breathing in lowlanders older than 40 years travelling from 760 m to 3'100 m.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of preventive acetazolamide intake on the sleep disordered breathing 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

185

Conditions

Altitude Hypoxia

Interventions

ACETAZOLAMIDE oral capsuleDRUG

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

Placebo oral capsuleDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

National Center of Cardiology and Internal Medicine

Bishkek, Kyrgyzstan

Outcomes

Primary Outcomes

Change in nocturnal oxygen desaturation index

Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group

Time frame: night 1 at 760m and night 1 at 3'100 m

Secondary Outcomes

Change in nocturnal oxygen saturation night 1 at 3'100m

Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group

Time frame: night 1 at 760m and night 1 at 3'100 m

Change in nocturnal oxygen saturation night 2 at 3'100m

Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group

Time frame: night 1 at 760m and night 2 at 3'100 m

Change in nocturnal oxygen desaturation index

Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group

Time frame: night 1 at 760m and night 2 at 3'100 m

Change in apnea/hypopnea index night 1 at 3'100m

Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group

Time frame: night 1 at 760m and night 1 at 3'100 m

Change in apnea/hypopnea index night 2 at 3'100m

Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group

Time frame: night 1 at 760m and night 2 at 3'100 m

Data from ClinicalTrials.gov

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