Validation of the Withings Hypertension Notification Feature (HTNF)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Withings
- 入组人数
- 2,500
- 试验地点
- 1
研究概览
简要总结
This retrospective, non-interventional clinical investigation evaluates the diagnostic performance of the Withings Hypertension Notification Feature (HTNF), a software-only medical device (SaMD) that analyzes demographic, anthropometric, and physiological parameters collected by Withings connected smart scales to identify patterns suggestive of hypertension. Ground-truth blood pressure measurements are obtained concurrently from Withings connected blood pressure monitors.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Withings Blood Pressure Monitor (reference) (Device)
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.
干预措施: Withings Hypertension Notification Feature (HTNF) (Device)