A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopa… (NCT07022925) | Clinical Trial Compass
RecruitingNot Applicable
A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
Canada110 participantsStarted 2025-07-04
Plain-language 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.
Who can participate
Age range35 Years – 55 Years
SexFEMALE
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Inclusion criteria
✓. Females between 35-55 years of age, inclusive
✓. Self-reported perimenopausal women experiencing hot flushes or night sweats
✓. 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:
✓. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements/medications, and sleep
✓. Provided voluntary and informed consent to participate in the study
✓. Generally healthy as determined by medical history with no unstable diagnosed medical conditions
Exclusion criteria
✕. Allergy or sensitivity to adhesive used for wearing the investigational device
The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing Vasomotor symptoms.
Timeframe: Day 0 to 14
2
The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing anxiety
Timeframe: Day 0 to 14
3
The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing sleep quality
Timeframe: Day 0 to 14
4
The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing perimenopausal symptoms considering confounders
Timeframe: Day 0 to 14
5
The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing perimenopausal symptoms considering confounders