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
Double-barrier method
Intrauterine devices
Allergy or sensitivity to adhesive used for wearing the investigational device
Self-reported use of a pacemaker
Self-reported unstable diagnosed anxiety disorder
Self-reported sleep disorder requiring medical treatment
IdentifyHer Limited
Lead sponsor
KGK Science Inc.
Collaborator