Actively Recruiting
An Observational Virtual 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
N/A
Total Duration
On this page
Sponsors
I
IdentifyHer Limited
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how accurately a wearable device can detect and characterize symptoms experienced by women during perimenopause and menopause. The study focuses on symptoms such as hot flashes, night sweats, anxiety, and sleep quality, comparing the device's data with self-reported symptoms recorded daily through an app. The goal is to understand how well the device's algorithm matches participants' own reports of their symptoms. Participants will use IndentifyHer's Peri, a commercial, non-invasive wearable sensor designed to monitor the frequency and severity of perimenopausal symptoms. They will wear this device continuously while also completing daily electronic diaries and questionnaires about stress, anxiety, and sleep for a period of two weeks. This combination allows researchers to compare the device's measurements with participants' self-reports. During the study, participants will be asked to maintain their usual lifestyle habits, including diet, exercise, supplements or medications, and sleep patterns. Researchers will collect data from the wearable device, daily app questionnaires, and stress and sleep assessments. The main outcomes measured are the accuracy of the device's algorithm in tracking vasomotor symptoms, anxiety, sleep quality, and overall perimenopausal symptoms during the 14-day study period. The study is observational and virtual, with involvement lasting approximately two weeks.
CONDITIONS
Brief 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 woman experiencing hot flushes or night sweats
- If able to have children, not pregnant, not planning pregnancy, and agrees to use approved birth control during the study
- Agrees to maintain current lifestyle including diet, exercise, supplements/medications, and sleep
- Provides voluntary and informed consent
- Generally healthy with no unstable medical conditions
You will not qualify if you...
- Allergy or sensitivity to the adhesive of 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 surgery during the study
- Average alcohol intake of 1 or more standard drink per day
- Alcohol or drug abuse in the past 12 months requiring treatment
- Use of medications or supplements that may affect device data
- Participation in other clinical studies within 30 days prior to screening
- Unable to give informed consent
- Any other condition or lifestyle factor that may affect study completion or pose risk to participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - 14 days
Participants wear a non-invasive, wearable device and use an app to track perimenopausal symptoms such as hot flashes, night sweats, anxiety, and sleep disturbances.
Daily self-reporting via app and continuous wearable device usage
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
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