Clinical trial NCT03536507: Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Altitude Hypoxia
Keywords: healthy participants older than 40 years
sleep disordered breathing
periodic breathing
prevention
acetazolamide
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2018-05-24
Enrollment: 185
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in nocturnal oxygen desaturation index
timeFrame: night 1 at 760m and night 1 at 3'100 m
Secondary outcomes:
measure: Change in nocturnal oxygen saturation night 1 at 3'100m
timeFrame: night 1 at 760m and night 1 at 3'100 m
measure: Change in nocturnal oxygen saturation night 2 at 3'100m
timeFrame: night 1 at 760m and night 2 at 3'100 m
measure: Change in nocturnal oxygen desaturation index
timeFrame: night 1 at 760m and night 2 at 3'100 m
measure: Change in apnea/hypopnea index night 1 at 3'100m
timeFrame: night 1 at 760m and night 1 at 3'100 m
measure: Change in apnea/hypopnea index night 2 at 3'100m
timeFrame: night 1 at 760m and night 2 at 3'100 m
measure: Change in subjective sleepiness and sleep quality
timeFrame: Day 1 and 2 at 760m and 3'100m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant M Sooronbaev, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Zürich
name: Michael Furian, MSc
role: PRINCIPAL_INVESTIGATOR
References: