RecruitingNCT07022925

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

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


Sponsor

IdentifyHer Limited

Enrollment

110 participants

Start Date

Jul 4, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 35 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable device can accurately detect and track symptoms of perimenopause — specifically hot flashes and night sweats — in women going through the transition to menopause. **You may be eligible if...** - You are a woman between 35 and 55 years old - You are in perimenopause and experiencing hot flashes or night sweats - You are not pregnant and are using an approved form of birth control if applicable - You are willing to keep your lifestyle (diet, exercise, sleep) as consistent as possible during the study - You are generally healthy with no unstable medical conditions **You may NOT be eligible if...** - You have an allergy or sensitivity to adhesives used in the device - You use a pacemaker - You have an unstable anxiety disorder - You have a sleep disorder that requires medical treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

KGK Science Inc.

London, Ontario, Canada

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NCT07022925


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