Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Change in nocturnal oxygen desaturation index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: ACETAZOLAMIDE oral capsule (Drug)
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
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Change in nocturnal oxygen desaturation index
时间窗: 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
次要结局
- Change in nocturnal oxygen saturation night 2 at 3'100m(night 1 at 760m and night 2 at 3'100 m)
- Change in nocturnal oxygen desaturation index(night 1 at 760m and night 2 at 3'100 m)
- Change in nocturnal oxygen saturation night 1 at 3'100m(night 1 at 760m and night 1 at 3'100 m)
- Change in apnea/hypopnea index night 2 at 3'100m(night 1 at 760m and night 2 at 3'100 m)
- Change in apnea/hypopnea index night 1 at 3'100m(night 1 at 760m and night 1 at 3'100 m)
- Change in subjective sleepiness and sleep quality(Day 1 and 2 at 760m and 3'100m)