Actively Recruiting
A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to 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
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
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N6B3L1
Actively Recruiting
Research Team
M
Marc Moulin, PhD
CONTACT
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
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