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Набор скоро начнётся NCT07597915

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

— Наблюдательное Perimenopause Menopause

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Perimenopause, Menopause. Базовые параметры: 35 лет — 55 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Feasibility: Retention [Срок оценки: From enrollment to the end of participation at 12 months]
  • Feasibility: Adherence [Срок оценки: From enrollment to the end of participation at 12 months]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07597915 · PRO-OT2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗