A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
NCT ID: NCT07022925
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2025-07-04
2025-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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IndentifyHer's Peri
IndentifyHer's Peri investigational device is a commercial, non-invasive, wearable sensor that works in combination with a digital platform to quantify and profile the frequency and severity of perimenopausal symptoms including hot flashes, night sweats, anxiety, and sleep disturbances.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
35 Years
55 Years
FEMALE
No
Sponsors
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KGK Science Inc.
INDUSTRY
IdentifyHer Limited
INDUSTRY
Responsible Party
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Principal Investigators
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David Crowley, MD
Role: PRINCIPAL_INVESTIGATOR
KGK Science Inc.
Locations
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KGK Science Inc.
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24IDCFI01
Identifier Type: -
Identifier Source: org_study_id
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