NCT07631715Active, not recruiting
Withings Hypertension Notification Retrospective Study
Validation of the Withings Hypertension Notification Feature (HTNF)
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2500 (estimated)
- First submitted
- 26 May 2026
- Start date
- 1 Mar 2026
- Primary completion date
- Jul 2026
- Lead sponsor
- Withings
- Diseases
- High blood pressure
- NCT number
- NCT07631715
What you commit to
- Study type: Observational
- Planned participants: 2500
- From 1 Mar 2026 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Users with physiological measurements falling outside plausible clinical ranges (BMI \< 10 or \> 100 kg/m2, age \< 18/22 or \> 100 years)
Other
- Users lacking valid weekly average systolic and diastolic blood pressure measurements (missing ground truth)
- 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)
Who the study is looking for
- 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)
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Withings SA Coordinator of this site? Confirm its status | Issy-les-Moulineaux | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.