Clinical Trial

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

Recruiting

Record status

This record was last updated September 18, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2025-06-06; most recent amendment 2025-09-17.

Status change: Not Yet Recruiting → Recruiting 2025-07-22

Trial Details

NCT Number	NCT07022925
Lead Sponsor	IdentifyHer Limited Collaborators: KGK Science Inc.
Conditions	Perimenopause, Perimenopausal Depression, Perimenopausal Insomnia, Perimenopausal Women, Menopausal Depression, Menopausal Hot Flashes, Menopausal and Postmenopausal Disorders, Menopausal Vasomotor Symptoms
Enrollment	110 participants
Start Date	2025-07-04
Primary Completion	2025-10 (estimated)
Study Completion	2025-10 (estimated)
Updated on ClinicalTrials.gov	2025-09-18