An Observational Virtual Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women
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.
• 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:
‣ 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
• 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