Our Transitions: Improving the Path to Menopause With Personal Digital Health Technologies
2026年5月14日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
1250
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sarah Goodday, PhD
- 電話番号：902-237-4235
- メール：sarah@4youandme.org
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
なし
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Feasibility: Retention
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月1日
一次修了 (推定)
2027年8月31日
研究の完了 (推定)
2027年8月31日
試験登録日
最初に提出
2026年5月14日
QC基準を満たした最初の提出物
2026年5月14日
最初の投稿 (実際)
2026年5月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月20日
QC基準を満たした最後の更新が送信されました
2026年5月14日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。