Withings Devices Follow-up Study - Hypertension | NCT06692413

Studies
Withings Devices Follow-up Study - Hypertension

NCT06692413

Sponsor

Withings

Status

Withdrawn

Last Update Posted

Feb 19, 2026Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Questionnaire

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The PI couldn't participate to the study finally

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Nov 1, 2024Actual

Completion Date

Nov 1, 2024Actual

First Submitted Date

Nov 12, 2024

First Submission Date that Met QC Criteria

Nov 14, 2024

First Posted Date

Nov 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2026

Last Update Posted Date

Feb 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Withings device users		Active Withings device users having at least 2 years of device data	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Users who consent to the study will receive a questionnaire every 3 months	Withings device users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prediction of uncontrolled hypertension	Correlation between uncontrolled hypertension, Withings data, and survey answers	2 years

Secondary Outcomes

Measure	Description	Time Frame
Correlation between Framingham risk score and EQ-5D-5L answers and Withings data	Correlation between Framingham risk score and EQ-5D-5L answers and Withings data	2 years
Number of Questionnaires answers per participant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female who are 21 years of age or older,
Participant living in the United States,
Participant with data recorded in WITHINGS database,
Active WITHINGS device users having at least 2 years of data,
Subject able to read, understand, and provide written informed consent,
Subject willing and able to participate in the study procedures as described in the consent form,
Subject able to communicate effectively with and willing to follow instructions from the study staff.

Exclusion Criteria:

Minors under 21 years old,
Subject who refused to participate in the study,
Subject who did not reply to the questionnaire,
Subject who objected to the processing of his or her data after the start of the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The population meeting the inclusion criteria will all live in the US, regular and active users of one or several WITHINGS devices, who agreed to receive notifications from Withings Clinical Operations department, and who have previously acquired a WITHINGS device. They will receive a notification through their WITHINGS application, offering them the opportunity to participate in the study. In case of a positive answer, the user will be redirected to the study information sheet.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
de Havenon, MD	Yale University School of Medicine, Dept of Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale University Medical School, Department of Neurology		New Haven	Connecticut	06150	United States

ID	Term
D006973	Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided