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NCT Number: NCT07022925

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

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.

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Key information

Conditions

Perimenopause Hot Flashes Menopausal Depression Menopausal Hot Flashes Menopausal Vasomotor Symptoms Menopausal and Postmenopausal Disorders Pathological Conditions, Signs and Symptoms Perimenopausal Depression Perimenopausal Insomnia Perimenopausal Women Signs and Symptoms

Age range

35 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

KGK Science Inc.

London, Ontario, N6B3L1, Canada

Location status: Recruiting

Location contact

David Crowley, MD

CONTACT

[email protected]

David Crowley, MD

PRINCIPAL_INVESTIGATOR

Marc Moulin, PhD

CONTACT

[email protected]

+12267819094;ext=300

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 vasomotor symptoms. Questionnaire answers include "not at all" to "extremely".

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

    Time frame: 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. Questionnaire answers include "not at all" to "nearly everyday".

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

    Time frame: 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. Questionnaire answers include "terrible" to "very well".

  4. 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

    Time frame: 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 of warmer environmental conditions. Questionnaire answers include "not at all" to "nearly all day".

  5. 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

    Time frame: 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 of an ethnically-diverse study population. Questionnaire answers include "not at all" to "nearly all day".

Study contacts

Contact information is provided by the study sponsor or research team.

Marc Moulin, PhD

CONTACT

[email protected]

+12267819094;ext=300

Sponsors and collaborators

Lead sponsor

IdentifyHer Limited

Industry

Collaborators

  • KGK Science Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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