Wearable device to track perimenopausal and menopausal symptoms
An Observational Virtual Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
This project will test whether a wearable sensor can accurately detect hot flashes, night sweats, sleep problems, and anxiety-related signals in women aged 35–55 going through perimenopause by comparing device readings with daily reports in an app.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 35 Years to 55 Years |
| Sex | Female |
| Sponsor | IdentifyHer Limited Industry-sponsored |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT07022925 on ClinicalTrials.gov |
What this trial studies
This observational study asks perimenopausal women to wear IdentifyHer’s non-invasive wearable sensor and complete a daily electronic diary plus questionnaires on stress, anxiety, and sleep. The device’s algorithm-generated events will be compared to participant self-reports in the app to measure agreement and accuracy. Outcomes will include metrics such as sensitivity, specificity, and overall concordance for vasomotor symptoms, sleep disturbances, and anxiety-related patterns. The study is run with KGK Science Inc. in London, Ontario and enrolls generally healthy women who report hot flashes or night sweats.
Who should consider this trial
Good fit: Women aged 35–55 who self-identify as perimenopausal, experience hot flushes or night sweats, are generally healthy, agree to use contraception if of child-bearing potential, and can comply with wearing the device and completing daily app entries are ideal candidates.
Not a fit: Women who are not experiencing vasomotor symptoms, are clearly postmenopausal, are pregnant or planning pregnancy, have allergies or sensitivities to wearable materials, or have unstable medical conditions are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the wearable could provide objective, continuous symptom tracking to help women and clinicians monitor perimenopausal symptoms and treatment effects.
How similar studies have performed: Previous research using physiological wearables to detect vasomotor events and sleep disturbances has shown promising but variable results, and rigorous validation against daily self-report remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Females between 35-55 years of age, inclusive 2. Self-reported perimenopausal women experiencing hot flushes or night sweats 3. 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 4. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements/medications, and sleep 5. Provided voluntary and informed consent to participate in the study 6. Generally healthy as determined by medical history with no unstable diagnosed medical conditions Exclusion Criteria: 1. Allergy or sensitivity to adhesive used for wearing the investigational device 2. Self-reported use of a pacemaker 3. Self-reported unstable diagnosed anxiety disorder 4. Self-reported sleep disorder requiring medical treatment 5. Self-reported skin conditions or sensitive skin around the area of application 6. Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study 7. Alcohol intake average of ˃1 standard drink per day 8. Alcohol or drug abuse within the last 12 months that has required treatment 9. 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) 10. Participation in other clinical research studies 30 days prior to screening 11. Individuals who are unable to give informed consent 12. 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
Where this trial is running
London, Ontario
- KGK Science Inc. — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: David Crowley, MD — KGK Science Inc.
- Study coordinator: Marc Moulin, PhD
- Email: mmoulin@kgkscience.com
- Phone: +12267819094;ext=300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.