NCT07022925

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: IdentifyHer Limited · Industry
• Sex: Female
• Age: 35 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perimenopause
• Perimenopausal Depression
• Perimenopausal Insomnia
• Perimenopausal Women
• Menopausal Depression
• Menopausal Hot Flashes
• Menopausal and Postmenopausal Disorders
• Menopausal Vasomotor Symptoms

Timeline

• Start date: 2025-07-04
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-06-15
• Last updated: 2025-09-18

Locations

1 site across 1 country: Canada