Investigation of Heart Rate Variability During the Menstrual Cycle

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.

Study Overview

• Status: Completed
• Conditions: Ovulation

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United Kingdom
  • Bedfordshire
    • Bedford, Bedfordshire, United Kingdom, MK44 3UP
      • SPD Development company Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

• Age 18 years and over
• Regular menstrual cycles

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate at time points throughout the menstrual cycle	1 month
Heart Rate Variability	Heart rate variability at time points throughout the menstrual cycle	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Day of ovulation	Day of ovulation determined by urinary LH surge +1 day	1 month
Fertile window	Fertile window onset determined by E3G surge	1 month
Fertile window closure	Fertile window closure determined by P3G rise	1 month

Collaborators and Investigators

• Sponsor: SPD Development Company Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 19, 2019
• Primary Completion (ACTUAL): October 2, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (ACTUAL): July 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-1039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No