HypertensionHTNFNCT07631715
Withings Hypertension Notification Retrospective Study
An observational study of Hypertension, run by Withings at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Withings Blood Pressure Monitor (reference) and Withings Hypertension Notification Feature (HTNF)
- Type of treatment
- Medical device
- How many people
- 2,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Withings Hypertension Notification Feature (HTNF)
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Withings Blood Pressure Monitor (reference), Withings Hypertension Notification Feature (HTNF)
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withings Blood Pressure Monitor (reference)Device
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.
Withings Hypertension Notification Feature (HTNF)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Withings Blood Pressure Monitor (reference); Device: Withings Hypertension Notification Feature (HTNF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm
Percentage of hypertensive user-weeks correctly flagged
Measured: up to 7 years
Stage-Adjusted Specificity (Sp) of the Withings HTNF Algorithm
Percentage of non-hypertensive user-weeks correctly not flagged
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Mar 2026
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Escourrou, MD, PhD, Principal investigator, Centre Interdisciplinaire du Sommeil, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631715
- Sponsor's protocol ID
- HTNF
- Acronym
- HTNF
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Withings Hypertension Notification Feature (HTNF)
- ClinicalTrials.gov ID
- NCT07631715
- Acronym / sponsor ID
- HTNF / HTNF
- Conditions
- Hypertension
- Keywords
- Hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Withings Smart Scale Users | – | Device: Withings Blood Pressure Monitor (reference), Device: Withings Hypertension Notification Feature (HTNF)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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 Smart Scale Users |
| 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. | Device | Withings Smart Scale Users |
Primary outcome
Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm
Time frame: up to 7 years
Percentage of hypertensive user-weeks correctly flagged
Stage-Adjusted Specificity (Sp) of the Withings HTNF Algorithm
Time frame: up to 7 years
Percentage of non-hypertensive user-weeks correctly not flagged
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Escourrou, MD, PhD principal investigator
Centre Interdisciplinaire du Sommeil, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Withings at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm (time frame: up to 7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.