HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women. A Randomized, Placebo-Controlled, Double-Blind Parallel Trial.
概览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Nocturnal oxygen desaturation index (ODI)
概览
简要总结
Randomized clinical trial evaluating the effect of acetazolamide on sleep disordered breathing in women compared to men travelling to 3600 m.
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
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives).
- •BMI \>18 kg/m2 and \<30 kg/m2
- •Born, raised and currently living at altitudes \<1000 m
- •Written informed consent
- •Premenopausal women with an eumenorrheic cycle
排除标准
- •Other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
- •Pregnancy or nursing
- •Anaemic (haemoglobin concentration \<10g/dl)
- •Any altitude trip \<4 weks before the study
- •Allergy to acetazolamide and other sulfonamides
研究组 & 干预措施
WOMEN - ACETAZOLAMIDE oral capsule
Acetazolamide 250 mg/day (capsules @125 mg; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.
干预措施: Acetazolamide (Drug)
MEN - ACETAZOLAMIDE oral capsule
Acetazolamide 250 mg/day (capsules @125 mg; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.
干预措施: Acetazolamide (Drug)
WOMEN - PLACEBO oral capsule
Placebo (capsules identically looking as acetazolamide capsules; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.
干预措施: Placebo (Drug)
MEN - PLACEBO oral capsule
Placebo (capsules identically looking as acetazolamide capsules; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.
干预措施: Placebo (Drug)
结局指标
主要结局
Nocturnal oxygen desaturation index (ODI)
时间窗: Night 1 at 760 m and Night 1 at 3600 m
Sex-related difference in the altitude-induced change in the ODI (number of ∆SpO2 \>3% per hour time in bed measured by pulse oximetry) between acetazolamide and placebo group.
次要结局
- Nocturnal oxygen saturation (SpO2)(Night 1 at 760 m and Night 2 at 3600 m)
- Apnea/hypopnea index (AHI)(Night 1 at 760 m and Night 2 at 3600 m)
- Subjective sleep quality(Night 1 at 760 m and Night 2 at 3600 m)
- Nocturnal oxygen desaturation index (ODI)(Night 1 at 760 m and Night 2 at 3600 m)