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Heart Rate Variability During the Menstrual Cycle

Sponsor
SPD Development Company Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04382001
Collaborator
(none)
28
Enrollment
1
Location
11.1
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    28 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Further Investigations of Heart Rate Variability During the Menstrual Cycle
    Actual Study Start Date :
    Jun 1, 2020
    Actual Primary Completion Date :
    May 6, 2021
    Actual Study Completion Date :
    May 6, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Heart rate [1 month]

      Heart rate at time points throughout the menstrual cycle

    2. Heart Rate [1 month]

      Heart rate variability at time points throughout the menstrual cycle

    3. Day of Ovulation [1 month]

      Day of ovulation determined by urinary LH surge +1 day

    4. Fertile Window [1 month]

      Fertile window onset determined by E3G surge

    5. Fertile window [1 month]

      Fertile window closure determined by P3G rise

    Secondary Outcome Measures

    1. Comparisons between wrist and chest band monitors [1 month]

      Agreement between wrist band and chest band heart rate data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SPD Development Company Ltd Bedford Bedfordshire United Kingdom MK44 3UP

    Sponsors and Collaborators

    • SPD Development Company Limited

    Investigators

    • Study Director: Sarah Johnson, SPD Development Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SPD Development Company Limited
    ClinicalTrials.gov Identifier:
    NCT04382001
    Other Study ID Numbers:
    • PROTOCOL-1196
    First Posted:
    May 11, 2020
    Last Update Posted:
    Aug 6, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 6, 2021