Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude
- Conditions
- Altitude Hypoxia
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03536507
- Lead Sponsor
- University of Zurich
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACETAZOLAMIDE oral capsule ACETAZOLAMIDE oral capsule Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m PLACEBO oral capsule Placebo oral capsule Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m
- Primary Outcome Measures
Name Time Method Change in nocturnal oxygen desaturation index night 1 at 760m and night 1 at 3'100 m Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
- Secondary Outcome Measures
Name Time Method Change in nocturnal oxygen saturation night 2 at 3'100m night 1 at 760m and night 2 at 3'100 m Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
Change in nocturnal oxygen desaturation index night 1 at 760m and night 2 at 3'100 m Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
Change in nocturnal oxygen saturation night 1 at 3'100m night 1 at 760m and night 1 at 3'100 m Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
Change in apnea/hypopnea index night 2 at 3'100m night 1 at 760m and night 2 at 3'100 m Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group
Change in apnea/hypopnea index night 1 at 3'100m night 1 at 760m and night 1 at 3'100 m Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group
Change in subjective sleepiness and sleep quality Day 1 and 2 at 760m and 3'100m Difference in altitude-induced change in subjective sleepiness and sleep quality assessed by a visual analog scale between acetazolamide and placebo group
Trial Locations
- Locations (1)
National Center of Cardiology and Internal Medicine
🇰🇬Bishkek, Kyrgyzstan