NCT06498544已完成不适用
HighCycle Study: Effect of High Altitude on Sleep Disordered Breathing in Women Related to Their Menstrual Cycle Phase. A Prospective Cohort Study at 3600 m.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Nocturnal oxygen saturation (SpO2)
研究概览
简要总结
Prospective cohort study investigating the menstrual cycle phase (MCP) dependent sleep disordered breathing (SDB) in women travelling to 3600 m.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Criteria: Inclusion Criteria:
- •Healthy, non-smoking 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, eumenorrheic cycle
排除标准
- •Other types of contraceptives (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
结局指标
主要结局
Nocturnal oxygen saturation (SpO2)
时间窗: Night 1 at 760 m and Night 1 at 3600 m
MCP-related difference in altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry.
次要结局
- Nocturnal oxygen desaturation index (ODI)(Night 1 at 760 m and Night 2 at 3600 m)
- 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)
研究者
研究点 (2)
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