Investigation of Heart Rate Variability During the Menstrual Cycle

NCT ID: NCT04008277

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-19

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Ovulation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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SPD Development Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Johnson

Role: STUDY_DIRECTOR

SPD Development company Ltd.

Locations

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SPD Development Company Ltd.

Bedford, Bedfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PROTOCOL-1039

Identifier Type: -

Identifier Source: org_study_id

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