A 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…
Conditions studied
Perimenopause, Perimenopausal Depression, Perimenopausal Insomnia, Perimenopausal Women, Menopausal Depression, Menopausal Hot Flashes, Menopausal and Postmenopausal Disorders, Menopausal Vasomotor Symptoms
About this study
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.
Primary outcomes
- The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing Vasomotor symptoms. (Day 0 to 14)
- The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing anxiety (Day 0 to 14)
- The accuracy of the developed algorithm from the investigational device compared to daily self-report questionnaire via an app in characterizing sleep quality (Day 0 to 14)
- 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 (Day 0 to 14)
- 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 (Day 0 to 14)
Eligibility information
Study locations
- KGK Science Inc., London, Ontario N6B3L1 Canada
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.