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A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women | Clinical Trials | Clareo Health

RECRUITING

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

NCT07022925•IdentifyHer Limited

View on ClinicalTrials.gov

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

Age

35 - 55 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Females between 35-55 years of age, inclusive
•2. Self-reported perimenopausal women experiencing hot flushes or night sweats
•3. Individuals of child-bearing potential must confirm they are not pregnant, do not plan to become pregnant, and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:
•* Double-barrier method
•* Intrauterine devices
•* Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
•* Vasectomy of partner at least 6 months prior to screening
•* Abstinence
•4. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements/medications, and sleep
•5. Provided voluntary and informed consent to participate in the study
+1 more criteria

Exclusion Criteria

•1. Allergy or sensitivity to adhesive used for wearing the investigational device
•2. Self-reported use of a pacemaker
•3. Self-reported unstable diagnosed anxiety disorder
•4. Self-reported sleep disorder requiring medical treatment
•5. Self-reported skin conditions or sensitive skin around the area of application
•6. Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study
•7. Alcohol intake average of ˃1 standard drink per day
•8. Alcohol or drug abuse within the last 12 months that has required treatment
•9. Current use of prescribed and/or over-the-counter (OTC) medications/supplements that may impact data recorded by the investigational device (see Section 7.3)
•10. Participation in other clinical research studies 30 days prior to screening
+2 more criteria

Locations (1)

KGK Science Inc.

London, Ontario, Canada

Key Dates

Start Date

July 4, 2025

Primary Completion Date

October 1, 2025

Completion Date

October 1, 2025

Last Updated

September 18, 2025

Enrollment

110

ESTIMATED participants

Conditions

PerimenopausePerimenopausal DepressionPerimenopausal InsomniaPerimenopausal WomenMenopausal DepressionMenopausal Hot FlashesMenopausal and Postmenopausal DisordersMenopausal Vasomotor Symptoms

Contacts

Marc Moulin, PhD

CONTACT

+12267819094;ext=300 mmoulin@kgkscience.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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