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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Stiffness
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 176

Contacts and Locations

• Study Contact: Name: Rui Yi YANG, PhD; Phone Number: +33 6 19 78 25 54; Email: ruiyi.yang@withings.com
• Study Contact Backup: Name: Aline Criton, PhD; Phone Number: +33 6 64 20 47 65; Email: aline.criton@withings.com

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 78015
      • Georges Pompidou European Hospital
      • Contact: Pierre Boutouyrie, Pr; Phone Number: +33 1 56 09 39 91; Email: pierre.boutouyrie@aphp.fr
  • Rhône-Alpes
    • Grenoble, Rhône-Alpes, France, 38043
      • CHU Grenoble
      • Contact: Jean-Louis Pépin, Pr; Phone Number: +33 4 76 76 50 85; Email: JPepin@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety use	The percentage of participant having adverse effects over the total number of participant included.	1 year

Collaborators and Investigators

• Sponsor: Withings
• Investigators: Principal Investigator: Pierre Boutouyrie, Pr, Georges Pompidou European Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 2, 2023
• Primary Completion (Anticipated): May 2, 2024
• Study Completion (Anticipated): November 2, 2024

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-A00776-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No