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Withings Hypertension Notification Retrospective Study (HTNF)

3. juni 2026 opdateret af: Withings

Validation of the Withings Hypertension Notification Feature (HTNF): A Retrospective Study Comparing Diagnostic Performance Against the FDA-Authorized Predicate Device (Apple Watch HTNF, K250507)

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. The study tests whether the Withings HTNF achieves diagnostic performance substantially equivalent to the FDA-authorized predicate device (Apple Watch HTNF, K250507) for the purpose of 510(k) clearance.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

2500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
    • Île-de-France Region
      • Issy-les-Moulineaux, Île-de-France Region, Frankrig, 92130
        • Withings SA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult consumer users (>= 18 years, >= 22 years in the US) of Withings connected smart scales (Body Cardio, Body Scan, Body Comp) with concurrent Withings connected blood pressure monitor data, who received the study information letter and did not opt out. The retrospective validation cohort is drawn from a HealthVerity-linked US subset to support subgroup analyses by race, ethnicity, prior hypertension diagnosis, and antihypertensive medication use.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Enhed: Withings Blood Pressure Monitor (reference)
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.
Enhed: Withings Hypertension Notification Feature (HTNF)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm
Tidsramme: up to 7 years
Percentage of hypertensive user-weeks correctly flagged
up to 7 years
Stage-Adjusted Specificity (Sp) of the Withings HTNF Algorithm
Tidsramme: up to 7 years
Percentage of non-hypertensive user-weeks correctly not flagged
up to 7 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Withings

Efterforskere

  • Ledende efterforsker: Pierre Escourrou, MD, PhD, Centre Interdisciplinaire du Sommeil, Paris, France

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2026

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. juli 2026

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HTNF

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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