Withings Hypertension Notification Retrospective Study (HTNF)
Validation of the Withings Hypertension Notification Feature (HTNF)
調査の概要
状態
条件
詳細な説明
Hypertension affects approximately 1.4 billion adults worldwide and is the leading modifiable risk factor for cardiovascular disease. The Withings Hypertension Notification Feature (HTNF) is a software-only medical device (Software as a Medical Device, SaMD) that analyzes demographic, anthropometric, and physiological parameter data opportunistically collected by Withings connected smart scales to identify patterns suggestive of hypertension and provide a notification to the user. Ground-truth hypertension status is defined at the user-week level as a weekly average systolic blood pressure (SBP) >= 130 mmHg or diastolic blood pressure (DBP) >= 80 mmHg (2017 ACC/AHA guideline), based on a minimum of 7 weekly blood pressure measurements from Withings BPM devices.
Data were collected retrospectively between 2019 and 2026 from consumer users of commercially available Withings smart scales who received an information letter and did not opt out. No prospective measurements or interventions are performed.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Île-de-France Region
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Issy-les-Moulineaux、Île-de-France Region、フランス、92130
- Withings SA
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Users of commercially purchased, consumer-grade Withings smart scales (models Body Cardio, Body Comp, Body Scan) in a standard home environment
- Concurrent ground-truth blood pressure data collected via Withings connected blood pressure monitors (BPM, BPM+, BPM Connect, or BPM Core)
- At least 7 blood pressure measurements within a given week to establish reliable weekly hypertension status classification
- Age >= 18 years (all regions) or >= 22 years (United States), consistent with the predicate device age requirement
- Receipt of the study information letter without exercising the right to opt out (for applicable regulatory jurisdictions)
Exclusion Criteria:
- Users lacking valid weekly average systolic and diastolic blood pressure measurements (missing ground truth)
- Users with physiological measurements falling outside plausible clinical ranges (BMI < 10 or > 100 kg/m2, age < 18/22 or > 100 years)
- Users who exercised their right to opt out of the retrospective study
- Users without an individual Withings account (shared accounts are excluded to prevent data contamination)
研究計画
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 |
介入・治療 |
|---|---|
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Withings Smart Scale Users
Retrospective cohort of adult consumer users of Withings connected smart scales (Body Cardio, Body Scan, Body Comp) with concurrent Withings blood pressure monitor measurements between 2019 and 2026.
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Ground-truth weekly average systolic and diastolic blood pressure measurements obtained from Withings connected blood pressure monitors (BPM [WPM02], BPM+ [WPM03], BPM Core [WPM04], BPM Connect [WPM05]), validated as non-invasive oscillometric blood pressure monitors per ISO 81060-2:2018.
Minimum 7 measurements per user-week required.
The Withings Hypertension Notification Feature (HTNF) is a software-only medical device (Software as a Medical Device, SaMD) that analyzes demographic, anthropometric, and physiological parameter data opportunistically collected by Withings connected smart scales to identify patterns suggestive of hypertension and provide a notification to the user.
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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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Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm
時間枠：up to 7 years
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Percentage of hypertensive user-weeks correctly flagged
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up to 7 years
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Stage-Adjusted Specificity (Sp) of the Withings HTNF Algorithm
時間枠：up to 7 years
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Percentage of non-hypertensive user-weeks correctly not flagged
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up to 7 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Pierre Escourrou, MD, PhD、Centre Interdisciplinaire du Sommeil, Paris, France
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。