Heart Rate Variability During the Menstrual Cycle

Ovulation Clinical Trial

Official title:

Further Investigations of Heart Rate Variability During the Menstrual Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382001
• Other study ID #: PROTOCOL-1196
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: May 6, 2021

Study information

• Verified date: August 2021
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 6, 2021
• Est. primary completion date: May 6, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ovulation

Locations

Country	Name	City	State
United Kingdom	SPD Development Company Ltd	Bedford	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Heart rate at time points throughout the menstrual cycle	1 month
Primary	Heart Rate	Heart rate variability at time points throughout the menstrual cycle	1 month
Primary	Day of Ovulation	Day of ovulation determined by urinary LH surge +1 day	1 month
Primary	Fertile Window	Fertile window onset determined by E3G surge	1 month
Primary	Fertile window	Fertile window closure determined by P3G rise	1 month
Secondary	Comparisons between wrist and chest band monitors	Agreement between wrist band and chest band heart rate data	1 month