Trials / Completed
CompletedNCT04008277
Investigation of Heart Rate Variability During the Menstrual Cycle
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- SPD Development Company Limited · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2019-07-19
- Primary completion
- 2019-10-02
- Completion
- 2019-12-31
- First posted
- 2019-07-05
- Last updated
- 2020-02-20
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04008277. Inclusion in this directory is not an endorsement.