Heart Rate Variability During the Menstrual Cycle

Further Investigations of Heart Rate Variability During the Menstrual Cycle

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.

Study Overview

• Status: Completed
• Conditions: Ovulation

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.

• Study Type: Observational
• Enrollment (Actual): 28

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: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

• Aged 18 years of age and over
• Regular menstrual cycles (23-35 days in length)-

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
• Undertaking any frequent travel or long-haul flights during the course of the study
• Does not have access to an Apple iPhone or iPad with Bluetooth 4.0 (or later) and iOS 10.0 (or later)

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	Heart rate variability at time points throughout the menstrual cycle	1 month
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	Fertile window closure determined by P3G rise	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparisons between wrist and chest band monitors	Agreement between wrist band and chest band heart rate data	1 month

Collaborators and Investigators

• Sponsor: SPD Development Company Limited
• Investigators: Study Director: Sarah Johnson, SPD Development Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): May 6, 2021
• Study Completion (ACTUAL): May 6, 2021

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (ACTUAL): May 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-1196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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