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Withings Hypertension Notification Retrospective Study

NCT07631715 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2026-07-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Withings

    lead INDUSTRY

Principal Investigators

  • Pierre Escourrou, MD, PhD · Centre Interdisciplinaire du Sommeil, Paris, France

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07631715 on ClinicalTrials.gov