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

Vascular Stiffness Clinical Trial

— WIVOP-Scales  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05823025
• Other study ID #: 2022-A00776-37
• Status: Not yet recruiting
• Start date: May 2, 2023
• Est. completion date: November 2, 2024

Study information

• Verified date: April 2023
• Source: Withings
• Contact: Rui Yi YANG, PhD
• Phone: +33 6 19 78 25 54
• Email: ruiyi.yang[@]withings.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: November 2, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vascular Stiffness

Intervention

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

Locations

Country	Name	City	State
France	CHU Grenoble	Grenoble	Rhône-Alpes
France	Georges Pompidou European Hospital	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Withings

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PWV measurement bias	Difference between the PWV measured and the PWV reference (m.s-1)	1 year
Primary	PWV measurement deviation	The standard deviation of the difference between the PWV measured and the PWV reference (m.s-1)	1 year
Secondary	Safety use	The percentage of participant having adverse effects over the total number of participant included.	1 year