Altitude Hypoxia
Conditions
Keywords
healthy participants older than 40 years, sleep disordered breathing, periodic breathing, prevention, acetazolamide
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.
Interventions
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
DRUGPlacebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
Sponsors
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 |
Countries
Kyrgyzstan
Outcome results
None listed