Our Transitions: Improving the Path to Menopause With Personal Digital Health Technologies

4YouandMe

Status: Not yet enrolling

Conditions: Menopause; Perimenopause

Study type: Observational

Funder types: Other

Identifiers

NCT07597915

PRO-OT2025

Details and patient eligibility

About

The goal of this observational study is to build knowledge about the path to menopause using subjective, self-reported and objectively measured information from multiple wearable study devices and a smartphone app. This study is being done in female individuals who are 35-55 years of age. The eventual aim of this work is two-fold; 1) to increase knowledge, awareness and education for individuals and clinicians about the lived experience of perimenopause and menopause through objectively measured data from digital study devices, and 2) to develop approaches to empower female individuals to manage this transition by learning what improves or worsens their symptoms.

Full description

The ultimate objective of this research is to determine the feasibility of using multiple wearable study devices and smartphone apps to detect, track and learn how to share insights about symptoms during the path to menopause. The investigators anticipate that up to 250 participants will participate for 6 to 9 months. Participants will complete surveys and active tasks in a study app that takes on average 5 minutes a day, be provided with an Oura Ring Gen 4 and a Fitbit Sense 2 and will be expected to wear them daily. Participants will be expected to check in with a research coordinator every two weeks to go over participations and provide feedback on the wearable devices and smartphone apps. A subset of participants will be invited to participate in an at-home daily urine hormone collection for 3 menstrual cycles, measuring hormones including Luteinizing Hormone (LH), Estrone-3-glucuronide (E3G), and Pregnanediol Glucuronide (PdG). A different subset will be invited to participate in a vasomotor detection cohort using the new Vire Clip that captures core body temperature through heat flow, the dynamics of respiratory effort, and skin conductance measures at multiple layers of the skin. There will be a 'Bring Your Own Device' cohort after the main cohort enrollment is complete, where those with a personal wearable device will be invited to participate in the use of the study app for 6 to 9 months. Investigators will collect self-reported subjective symptoms and objectively measured physiological information to understand what participants learn about the use of these tools in tracking peri/menopausal symptoms. This study is done in collaboration between 4YouandMe, Women Living Better, Vector Institute, and is funded by the Steven and Alexandra Cohen Foundation.

Enrollment: 1,250 estimated patients

Sex: Female

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are 35-55 years old
• Reside in the US or Canada
• Are able to speak, write, and read English
• Are able to provide informed consent
• Have a personally owned iPhone (iOS Version 16.4)

Exclusion criteria

• Are not willing to wear a wearable study device
• Have a hormonal intrauterine device (IUD)
• Are taking birth control pills
• Are taking systemic estrogen or progesterone
• Have been diagnosed with Polycystic ovary syndrome (PCOS)
• Are taking the following medications (cancer treatment that affects the menstrual cycle, thyroid medication)
• Have had the following procedures (hysterectomy [removal of uterus], bilateral, oophorectomy [removal of both ovaries], endometrial ablation [surgery that destroys the lining of the uterus])
• Are currently pregnant, attempting to conceive, recently pregnant and not yet cycling and currently breast feeding

Trial design

1,250 participants in 4 patient groups

Main Cohort

Description:

Up to 250 participants aged 35-55 years old, residing in the US or Canada, who will be asked to complete surveys and active tasks in a study app, and use the Oura Ring Gen 4 and Fitbit Sense 2 daily. Participants will meet with research coordinators every 2 weeks to help support participation efforts and collect information on how the study and device use are going.

Hormone Sub-Cohort

Description:

A sub-cohort of up to 75 participants will be invited to participate in a hormone sub-cohort. If the participant agrees to participate in this sub-cohort, they will be asked to complete daily at-home urine hormone samples provided to them for 3 consecutive menstrual cycles. The hormone sub-cohort procedure consists of peeing on a disposable urine test strip in the morning and then using a digital analyzer to produce the results, measuring Luteinizing Hormone (LH), Estrone-3-glucuronide (E3G), and Pregnanediol Glucuronide (PdG).

Bring Your Own Device (BYOD) Open Arm

Description:

Once enrollment is complete in the main arm, and if the participant owns their own personal wearable device that includes an Oura ring, a Garmin smartwatch, Applewatch or Fitbit, they may be able to participate in the BYOD arm where they will participate by using the study app and providing the study investigators access to their wearable data. They will be asked permission for this wearable data sharing when they first download the study app during a number of opt-in screens. Up to 1000 participants may be enrolled in the BYOD arm.

Vire Clip Vasomotor Detection Sub-Cohort

Description:

A subset of up to 70 participants will be invited to participate in a vasomotor detection cohort that will involve the use of a new wearable (Vire) clip capable of capturing core body temperature through heat flow, the dynamics of respiratory effort, and skin conductance measures at multiple layers into the skin. We want to learn whether these new wearable-derived signals could be used to detect when a vasomotor event will occur, like a hot flash, night sweat, cold sweat or feelings of sudden heating. If you meet certain eligibility criteria, you will be mailed the Vire clip and given instructions on how to set it up and sync with the study app. The Vire clip is a small clip that can be clipped onto the inside of your underwear.