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

14. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

1250

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

N/A

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.
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).
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.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility: Retention
Zeitfenster: From enrollment to the end of participation at 12 months
Proportion of participants retained according to study protocol
From enrollment to the end of participation at 12 months
Feasibility: Adherence
Zeitfenster: From enrollment to the end of participation at 12 months
Mean adherence to completing in-app daily study measures
From enrollment to the end of participation at 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

4YouandMe

Mitarbeiter

Steven & Alexandra Cohen Foundation

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

31. August 2027

Studienabschluss (Geschätzt)

31. August 2027

Studienanmeldedaten

Zuerst eingereicht

14. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Mai 2026

Zuerst gepostet (Tatsächlich)

20. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • PRO-OT2025

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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