An observational study in Hypertension, sponsored by Withings. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Withings · Observational
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Withings is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Withings Blood Pressure Monitor (reference) · Device: Withings Hypertension Notification Feature (HTNF)
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.
Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm
Percentage of hypertensive user-weeks correctly flagged
Time frame: up to 7 years
Stage-Adjusted Specificity (Sp) of the Withings HTNF Algorithm
Percentage of non-hypertensive user-weeks correctly not flagged
Time frame: up to 7 years
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Jul 2026, 4 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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