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

Sponsor

Withings (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05823025

Collaborator

(none)

176

Enrollment

Locations

18.1

Anticipated Duration (Months)

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Vascular Stiffness	Other: PWV measurement

Detailed Description

Patients likely to have a high PWV (having hypertension, sleep apnea or chronic obstructive pulmonary disease) are included in hospitals. Each patient will have his PWV measured with Withings WBS08 and WBS12 and its reference the SphygmoCor CvMS.

Study Design

Study Type:

Observational

Anticipated Enrollment :

176 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Withings Study to Analyze the Accuracy of Pulse Wave Velocity Measurement With Bathroom Scales

Anticipated Study Start Date :

May 2, 2023

Anticipated Primary Completion Date :

May 2, 2024

Anticipated Study Completion Date :

Nov 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
Hypertension Hypertensive patient	Other: PWV measurement Patient will have its PWV measured with the reference (the SphygmoCor) and by stepping on Withings bathroom scales WBS08 and WBS12.
Sleep apnea or COPD Patient having sleep apnea or COPD (Chronic obstructive pulmonary disease)	Other: PWV measurement Patient will have its PWV measured with the reference (the SphygmoCor) and by stepping on Withings bathroom scales WBS08 and WBS12.

Arm

Intervention/Treatment

Hypertension

Hypertensive patient

Other: PWV measurement

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

Sleep apnea or COPD

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

Other: PWV measurement

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

Outcome Measures

Primary Outcome Measures

PWV measurement bias [1 year]
Difference between the PWV measured and the PWV reference (m.s-1)
PWV measurement deviation [1 year]
The standard deviation of the difference between the PWV measured and the PWV reference (m.s-1)

Secondary Outcome Measures

Safety use [1 year]
The percentage of participant having adverse effects over the total number of participant included.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georges Pompidou European Hospital	Paris	Ile De France	France	78015
2	CHU Grenoble	Grenoble	Rhône-Alpes	France	38043

Sponsors and Collaborators

Withings

Investigators

Principal Investigator: Pierre Boutouyrie, Pr, Georges Pompidou european hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Withings

ClinicalTrials.gov Identifier:

NCT05823025

Other Study ID Numbers:

2022-A00776-37

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 26, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 26, 2023