Withings Hypertension Notification Retrospective Study (HTNF)
Validation of the Withings Hypertension Notification Feature (HTNF)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Île-de-France Region
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Issy-les-Moulineaux, Île-de-France Region, 프랑스, 92130
- Withings SA
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Pierre Escourrou, MD, PhD, Centre Interdisciplinaire du Sommeil, Paris, France
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .