Withings Study to Analyze the Accuracy of Pulse Wave Velocity Measurement With Bathroom Scales (WIVOP-Scales)

NCT05823025 | Active Not Recruiting

• 1 other identifier: 2022-A00776-37
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to evaluate the diagnostic performance of Withings bathroom scales WBS08 and WBS12 to measure PWV (Pulse Wave Velocity).

Conditions

Vascular Stiffness

Outcome Measures

Primary Outcomes (2)

• PWV measurement bias

  Difference between the PWV measured and the PWV reference (m.s-1)

  1 year

• PWV measurement deviation

  The standard deviation of the difference between the PWV measured and the PWV reference (m.s-1)

  1 year

Secondary Outcomes (1)

• Safety use

  1 year

Study Arms (2)

Hypertension

Hypertensive patient

Other: PWV measurement

Sleep apnea or COPD

Patient having sleep apnea or COPD (Chronic obstructive pulmonary disease)

Other: PWV measurement

Interventions

PWV measurement OTHER

Patient will have its PWV measured with the reference (the SphygmoCor) and by stepping on Withings bathroom scales WBS08 and WBS12.

Hypertension; Sleep apnea or COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient have chronic disease (hypertension, sleep apnea, BPCO) likely to have a high PWV.

You may qualify if:

• The subject is an adult, man or woman (18 years old or more),
• Subjects affiliated or eligible to a social security system,
• Subjects having expressed their consent to take part in the study.
• Two subsets of patients will be included in the study :
• Hypertensive patient
• Patient having sleep apnea or COPD (Chronic obstructive pulmonary disease)

You may not qualify if:

• Minors under 18 years old,
• Subject is pregnant,
• Subjects having a pacemaker or an ICD (Implantable cardioverter defibrillator),
• Subjects having refused to give their consent,
• Vulnerable subjects according to the French regulation in force:
• Individuals deprived of liberty by a court, medical or administrative order,
• Individuals legally protected or unable to express their consent to take part in the study,
• Individuals unaffiliated to or not beneficiary of a social security system,
• Individuals who fit in multiple categories above,
• Individuals linguistically or mentally unable to express their consent,
• Individuals having a lower limb amputation bigger than toes,
• Individuals not able to stand still for a few minutes.

Sponsors & Collaborators

• Withings: lead

Study Sites (2)

CHU Grenoble

Grenoble, Auvergne-Rhône-Alpes, 38043, France

Location

Georges Pompidou European Hospital

Paris, Île-de-France Region, 78015, France

Location

Study Officials

• Pierre Boutouyrie, Pr

  Georges Pompidou european hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 21, 2023
• Study Start: June 16, 2023
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)