Our Transitions: Improving the Path to Menopause With Personal Digital Health Technologies
14 de mayo de 2026 actualizado por: 4YouandMe
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
1250
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Sarah Goodday, PhD
- Número de teléfono: 902-237-4235
- Correo electrónico: sarah@4youandme.org
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
N/A
Método de muestreo
Muestra no probabilística
Población de estudio
Eligible participants will live in the US or Canada.
Up to 250 participants will be invited to participate in the main cohort, 75 in the hormone sub-cohort, and 70 in the Vire clip sub-cohort.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Main Cohort
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.
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Hormone Sub-Cohort
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).
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Bring Your Own Device (BYOD) Open Arm
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.
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Vire Clip Vasomotor Detection Sub-Cohort
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasibility: Retention
Periodo de tiempo: From enrollment to the end of participation at 12 months
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Proportion of participants retained according to study protocol
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From enrollment to the end of participation at 12 months
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Feasibility: Adherence
Periodo de tiempo: From enrollment to the end of participation at 12 months
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Mean adherence to completing in-app daily study measures
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From enrollment to the end of participation at 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de mayo de 2026
Finalización primaria (Estimado)
31 de agosto de 2027
Finalización del estudio (Estimado)
31 de agosto de 2027
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de mayo de 2026
Publicado por primera vez (Actual)
20 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- PRO-OT2025
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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