Withings Hypertension Notification Retrospective Study (HTNF)
Validation of the Withings Hypertension Notification Feature (HTNF): A Retrospective Study Comparing Diagnostic Performance Against the FDA-Authorized Predicate Device (Apple Watch HTNF, K250507)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Hypertension affects approximately 1.4 billion adults worldwide and is the leading modifiable risk factor for cardiovascular disease. In September 2025, the FDA granted 510(k) authorization (K250507) to Apple Inc. for a Hypertension Notification Feature on Apple Watch, establishing the first regulatory precedent for consumer wearable-based hypertension screening.
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.
The co-primary endpoints are the stage-adjusted sensitivity and stage-adjusted specificity of the Withings HTNF algorithm on a held-out validation set, evaluated via a conjunctive intersection-union test (IUT) at one-sided alpha = 0.025. Stage adjustment is performed via Direct Standardization to the predicate's stage distribution. Confidence intervals are derived using BCa bootstrap resampling with at least 10,000 replicates.
Secondary endpoints include stage-specific Se/Sp, PPV/NPV, AUC-ROC, subgroup performance (age, sex, BMI, race/ethnicity, device model, prior HTN diagnosis, antihypertensive medication), and time-to-first-false-positive analyses. For the US cohort, race, ethnicity, diagnosis, and medication history are obtained via linkage to the HealthVerity claims database.
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
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Île-de-France Region
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Issy-les-Moulineaux, Île-de-France Region, Francia, 92130
- Withings SA
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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.
The held-out validation subset (~2,500 users) is drawn from the HealthVerity-linked US cohort to support stage-adjusted Sensitivity and Specificity primary endpoints and subgroup analyses.
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Pierre Escourrou, MD, PhD, Centre Interdisciplinaire du Sommeil, Paris, France
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Inizio studio (Effettivo)
Completamento primario (Stimato)
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Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HTNF
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