Observational Study of a Wearable Sensor to Track Perimenopausal Symptoms in Women Aged 35 to 55

What this Trial Is About

This research aims to evaluate how accurately a wearable device can detect and characterize symptoms experienced by women during perimenopause and menopause. The study focuses on symptoms such as hot flashes, night sweats, anxiety, and sleep quality, comparing the devices data with self-reported symptoms recorded daily through an app. The goal is to understand how well the devices algorithm matches participants own reports of their symptoms. Participants will use IndentifyHers Peri, a commercial, non-invasive wearable sensor designed to monitor the frequency and severity of perimenopausal symptoms. They will wear this device continuously while also completing daily electronic diaries and questionnaires about stress, anxiety, and sleep for a period of two weeks. This combination allows researchers to compare the devices measurements with participants self-reports. During the study, participants will be asked to maintain their usual lifestyle habits, including diet, exercise, supplements or medications, and sleep patterns. Researchers will collect data from the wearable device, daily app questionnaires, and stress and sleep assessments. The main outcomes measured are the accuracy of the devices algorithm in tracking vasomotor symptoms, anxiety, sleep quality, and overall perimenopausal symptoms during the 14-day study period. The study is observational and virtual, with involvement lasting approximately two weeks.

A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women