RecruitingNot Applicable

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

Canada110 participantsStarted 2025-07-04

Plain-language 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.

Who can participate

Age range

35 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Day 0 to 14

Trial details

NCT IDNCT07022925

SponsorIdentifyHer Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-10

Contact for this trial

Marc Moulin, PhD

+12267819094;ext=300 mmoulin@kgkscience.com

View on ClinicalTrials.gov More Perimenopause trials

Plain-language summary

Who can participate

Age range

35 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
. 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

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Day 0 to 14