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临床试验/NCT04008277
NCT04008277已完成不适用

Investigation of Heart Rate Variability During the Menstrual Cycle

SPD Development Company Limited1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Heart Rate Variability

研究概览

简要总结

In this study, women will be required to wear a heart rate monitor continuously and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.

详细描述

This pilot study is a prospective observational study of women's heart rate and heart rate variability throughout one complete menstrual cycle. A minimum of 10 volunteers aged 18 years of age or over will be recruited via a variety of methods according to the criteria detailed in section 9. They will be required to wear a heart rate monitor continuously and collect daily early morning urine samples throughout one menstrual cycle.

Urine samples will be returned to SPD on a regular basis for measurement of urinary hormones related to pregnancy and fertility. Data collected via the monitor including heart rate and heart rate variability will be downloaded for comparison.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 years and over
  • Regular menstrual cycles

排除标准

  • Taking any hormonal medications
  • Taking any medications that may affect heart rate
  • Known heart condition or use of a pacemaker
  • Skin condition where there is sensitivity to wearing a skin monitor
  • Currently suffering with anxiety or panic attacks
  • Pregnant or breastfeeding

结局指标

主要结局

Heart Rate Variability

时间窗: 1 month

Heart rate variability at time points throughout the menstrual cycle

Heart Rate

时间窗: 1 month

Heart rate at time points throughout the menstrual cycle

次要结局

  • Fertile window(1 month)
  • Day of ovulation(1 month)
  • Fertile window closure(1 month)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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