Hypertension
Conditions
Keywords
Hypertension
Brief 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.
Detailed description
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.
Interventions
DEVICEWithings 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.
DEVICEWithings 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
Withings
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm | up to 7 years | Percentage of hypertensive user-weeks correctly flagged |
| Stage-Adjusted Specificity (Sp) of the Withings HTNF Algorithm | up to 7 years | Percentage of non-hypertensive user-weeks correctly not flagged |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPierre Escourrou, MD, PhD
Centre Interdisciplinaire du Sommeil, Paris, France
Outcome results
None listed