Our Transitions: Improving the Path to Menopause With Personal Digital Health Technologies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Perimenopause, Menopause. Basic parameters: 35 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Primary outcome measures
- Feasibility: Retention [Time frame: From enrollment to the end of participation at 12 months]
- Feasibility: Adherence [Time frame: From enrollment to the end of participation at 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07597915 · PRO-OT2025