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

NCT07022925 | Recruiting

• 1 other identifier: 24IDCFI01
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Menopause; Perimenopause; Vasomotor symptoms; Hot flashes; IdentifyHer; Peri; Perimenopausal symptoms

Outcome Measures

Primary Outcomes (5)

• The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing Vasomotor symptoms.

  The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing vasomotor symptoms. Questionnaire answers include "not at all" to "extremely".

  Day 0 to 14

• The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing anxiety

  The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing anxiety. Questionnaire answers include "not at all" to "nearly everyday".

  Day 0 to 14

• The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing sleep quality

  The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing sleep quality. Questionnaire answers include "terrible" to "very well".

  Day 0 to 14

• The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing perimenopausal symptoms considering confounders

  The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing perimenopausal symptoms considering confounders of warmer environmental conditions. Questionnaire answers include "not at all" to "nearly all day".

  Day 0 to 14

• The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing perimenopausal symptoms considering confounders

  The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing perimenopausal symptoms considering confounders of an ethnically-diverse study population. Questionnaire answers include "not at all" to "nearly all day".

  Day 0 to 14

Study Arms (1)

IndentifyHer's Peri

IndentifyHer's Peri investigational device is a commercial, non-invasive, wearable sensor that works in combination with a digital platform to quantify and profile the frequency and severity of perimenopausal symptoms including hot flashes, night sweats, anxiety, and sleep disturbances.

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

N/A - virtual study. Participants are recruited online.

You may qualify if:

• Females between 35-55 years of age, inclusive
• Self-reported perimenopausal women experiencing hot flushes or night sweats
• 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
• Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements/medications, and sleep
• Provided voluntary and informed consent to participate in the study
• Generally healthy as determined by medical history with no unstable diagnosed medical conditions

You may not qualify if:

• Allergy or sensitivity to adhesive used for wearing the investigational device
• Self-reported use of a pacemaker
• Self-reported unstable diagnosed anxiety disorder
• Self-reported sleep disorder requiring medical treatment
• Self-reported skin conditions or sensitive skin around the area of application
• Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study
• Alcohol intake average of ˃1 standard drink per day
• Alcohol or drug abuse within the last 12 months that has required treatment
• 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)
• Participation in other clinical research studies 30 days prior to screening
• Individuals who are unable to give informed consent
• Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Sponsors & Collaborators

• IdentifyHer Limited: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

+12267819094;ext=300; mmoulin@kgkscience.com

Study Design

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

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: July 4, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-06

Locations

CA (1)