Actively Recruiting
Observational Virtual Study to Evaluate a Wearable Device's Accuracy in Tracking Perimenopausal Symptoms in Women
Led by IdentifyHer Limited · Updated on 2025-09-18
110
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
I
IdentifyHer Limited
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of a wearable device in capturing perimenopausal and menopausal symptoms such as hot flashes, night sweats, anxiety, and sleep quality. The study focuses on comparing the device's data through an algorithm to daily self-reported symptoms collected via an app. This observational trial aims to better understand how well the device can monitor these symptoms in women aged 35 to 55 who are experiencing perimenopause. Participants will wear IndentifyHer's non-invasive sensor while completing daily electronic diaries and questionnaires about stress, anxiety, and sleep over a two-week period. The study does not involve treatment but observes and collects data through the wearable device and app-based self-reports. The primary measurements focus on the accuracy of the device's algorithm compared to the daily self-reports from day 0 to day 14. During the study, participants will be monitored for vasomotor symptoms, anxiety, and sleep quality through both the wearable device and app questionnaires. Researchers will analyze the device's ability to characterize perimenopausal symptoms considering various confounding factors. The study includes safety monitoring regarding skin sensitivity to the device and participants' general health status. Total participation lasts for 14 days, during which continuous data collection and daily self-reporting occur.
CONDITIONS
Official Title
A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female between 35 and 55 years of age, inclusive
- Self-reported perimenopausal women experiencing hot flushes or night sweats
- If of child-bearing potential, not pregnant, not planning pregnancy, and agrees to use an approved birth control method during the study
- Agrees to maintain current lifestyle including diet, exercise, supplements/medications, and sleep throughout the study
- Provided voluntary and informed consent to participate
- Generally healthy with no unstable diagnosed medical conditions
You will not qualify if you...
- Allergy or sensitivity to adhesive used for the investigational device
- Use of a pacemaker
- Unstable diagnosed anxiety disorder
- Sleep disorder requiring medical treatment
- Skin conditions or sensitive skin around the device application area
- Surgery in the past three months or planned during the study
- Average alcohol intake of 1 or more standard drinks per day
- Alcohol or drug abuse requiring treatment within the last 12 months
- Current use of medications or supplements that may affect device data
- Participation in other clinical research within 30 days prior to screening
- Unable to give informed consent
- Any other condition or lifestyle factor that may affect study completion or participant safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N6B3L1
Actively Recruiting
Research Team
M
Marc Moulin, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Frequently Asked Questions
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