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临床试验/NCT03128983
NCT03128983已完成不适用

Variations of Physiological Data Throughout the Menstrual Cycle

Ava AG0 个研究点目标入组 41 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
主要终点
Correlation between menstrual cycle dynamics and physiology

研究概览

简要总结

Research results suggest changes of physiological parameters such as heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion during the menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record these parameters. The present study aims to evaluate whether there is a correlation between physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine ovulation test and the onset of menses. To collect data women will wear two smartwatches and a smartshirt at night. All three devices are CE-approved for sports and fitness.

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy, non-pregnant women aged 20-40 years (healthy volunteers)
  • Regular cycling (28 days +/- 2)
  • Non-hormonal contraception methods used
  • German-speaking
  • Written informed consent to participate in the study

排除标准

  • Any health-related issues that may affect menstrual cycle
  • Any consumption of medication or other substances that may affect the menstrual cycle or any of the physiological parameters investigated
  • Frequent travel between time zones
  • Sleeping disorders

结局指标

主要结局

Correlation between menstrual cycle dynamics and physiology

时间窗: During 1 menstrual cycle between 24 days and 35 days

Correlation between a combination of the physiological parameters heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion and menstrual cycle dynamics.

次要结局

未报告次要终点

研究者

发起方
Ava AG
申办方类型
Industry
责任方
Sponsor

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Physiological Data in the Menstrual Cycle | 临床试验