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

Launched by IDENTIFYHER LIMITED · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new wearable device can track symptoms related to perimenopause and menopause, such as hot flashes, sleep issues, and anxiety. The main goal is to see if the information collected by this device is accurate compared to what participants report themselves through an app. Women aged 35 to 55 who are experiencing symptoms like hot flashes or night sweats may be eligible to participate.

If you decide to join the study, you will wear a non-invasive sensor and fill out a daily diary on your stress, anxiety, and sleep quality. It’s important to maintain your usual lifestyle during the study and to confirm you’re not pregnant or planning to become pregnant. The study has specific criteria for who can join, so you'll need to meet certain health and lifestyle conditions. This trial is not yet recruiting participants, but it aims to help improve understanding of perimenopausal symptoms and how they can be managed.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Females between 35-55 years of age, inclusive
• • 2. Self-reported perimenopausal women experiencing hot flushes or night sweats
• 3. 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
• • 4. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements/medications, and sleep
• • 5. Provided voluntary and informed consent to participate in the study
• • 6. Generally healthy as determined by medical history with no unstable diagnosed medical conditions
• Exclusion Criteria:
• • 1. Allergy or sensitivity to adhesive used for wearing the investigational device
• • 2. Self-reported use of a pacemaker
• • 3. Self-reported unstable diagnosed anxiety disorder
• • 4. Self-reported sleep disorder requiring medical treatment
• • 5. Self-reported skin conditions or sensitive skin around the area of application
• • 6. Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study
• • 7. Alcohol intake average of ˃1 standard drink per day
• • 8. Alcohol or drug abuse within the last 12 months that has required treatment
• • 9. Current use of prescribed and/or over-the-counter (OTC) medications/supplements that may impact data recorded by the investigational device (see Section 7.3)
• • 10. Participation in other clinical research studies 30 days prior to screening
• • 11. Individuals who are unable to give informed consent
• • 12. Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant