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NCT03536507 Clinical Trial

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

Altitude Hypoxia Clinical Trial

Official title:
Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03536507
Other study ID # 2018-01-8/305C
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 15, 2018
Est. completion date August 2, 2018

Study information
Verified date November 2021
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 185
Est. completion date August 2, 2018
Est. primary completion date August 2, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ACETAZOLAMIDE oral capsule
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
• Placebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m

Locations
Country Name City State
Kyrgyzstan National Center of Cardiology and Internal Medicine Bishkek

Sponsors (2)
Lead Sponsor Collaborator
University of Zurich National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 night 1 at 760m and night 1 at 3'100 m
Secondary 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 night 1 at 760m and night 1 at 3'100 m
Secondary 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 night 1 at 760m and night 2 at 3'100 m
Secondary 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 night 1 at 760m and night 2 at 3'100 m
Secondary 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 night 1 at 760m and night 1 at 3'100 m
Secondary 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 night 1 at 760m and night 2 at 3'100 m
Secondary Change in subjective sleepiness and sleep quality Difference in altitude-induced change in subjective sleepiness and sleep quality assessed by a visual analog scale between acetazolamide and placebo group Day 1 and 2 at 760m and 3'100m
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