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

Not yet recruiting

• Conditions: Vascular Stiffness
• Interventions: Other: PWV measurement

• Registration Number: NCT05823025
• Lead Sponsor: Withings

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).

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 Timeline

• Study First Submitted: 2023-03-24
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-21
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26
• Study Start: 2023-05-02
• Primary Completion: 2024-05-02
• Study Completion: 2024-11-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sleep apnea or COPD	PWV measurement	Patient having sleep apnea or COPD (Chronic obstructive pulmonary disease)
Hypertension	PWV measurement	Hypertensive patient

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety use	1 year	The percentage of participant having adverse effects over the total number of participant included.

Trial Locations

Locations (2)

Georges Pompidou European Hospital; 🇫🇷 Paris, Ile De France, France

CHU Grenoble; 🇫🇷 Grenoble, Rhône-Alpes, France