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A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women

NCT07022925 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2025-09-18

No results posted yet for this study

Summary

The goal of this observational study is to investigate the accuracy of the device in characterizing perimenopausal and menopausal symptoms including vasomotor symptoms, anxiety, sleep quality compared to self-reported symptoms via an app. The main question it aims to answer is:

What is the accuracy of the developed algorithm from the investigational device compared to daily self-report via an app in characterizing perimenopausal symptoms?

Participants will be asked to wear IndentifyHer's wearable non-invasive sensor and complete a daily electronic diary and questionnaires on stress, anxiety, and sleep.

Conditions

  • Perimenopause
  • Perimenopausal Depression
  • Perimenopausal Insomnia
  • Perimenopausal Women
  • Menopausal Depression
  • Menopausal Hot Flashes
  • Menopausal and Postmenopausal Disorders
  • Menopausal Vasomotor Symptoms

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • IdentifyHer Limited

    lead INDUSTRY

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-04
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07022925 on ClinicalTrials.gov