NCT04382001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

May 6, 2020

Last Update Submit

August 5, 2021

Conditions

Ovulation

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Comparisons between wrist and chest band monitors

    1 month

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult female
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

Study Officials

  • Sarah Johnson

    SPD Development Company

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

June 1, 2020

Primary Completion

May 6, 2021

Study Completion

May 6, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

GB(1)