NCT04382001

Heart Rate Variability During the Menstrual Cycle

Further Investigations of Heart Rate Variability During the Menstrual Cycle

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: SPD Development Company Limited · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

In this study, women will be required to wear a chest heart rate monitor and wrist heart rate monitor daily 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.

Detailed description

This 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 chest heart rate monitor and wrist heart rate monitor for 1 hour each day, and throughout the night for one menstrual cycle. In addition, a daily early morning urine sample will be collected throughout the study. 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 monitors including heart rate and heart rate variability will be downloaded for comparison.

Conditions

• Ovulation

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-05-06
• Completion: 2021-05-06
• First posted: 2020-05-11
• Last updated: 2021-08-06

Locations

1 site across 1 country: United Kingdom