NCT07022925 A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
| NCT ID | NCT07022925 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IdentifyHer Limited |
| Condition | Perimenopause |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-07-04 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2025-07-04 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
David Crowley, MD
PRINCIPAL INVESTIGATOR
KGK Science Inc.
Frequently Asked Questions
Who can join the NCT07022925 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 55 Years, studying Perimenopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07022925 currently recruiting?
Yes, NCT07022925 is actively recruiting participants. Contact the research team at mmoulin@kgkscience.com for enrollment information.
Where is the NCT07022925 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT07022925 clinical trial?
NCT07022925 is sponsored by IdentifyHer Limited. The principal investigator is David Crowley, MD at KGK Science Inc.. The trial plans to enroll 110 participants.