Vascular Stiffness Clinical Trial
— WIVOP-ScalesOfficial title:
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).
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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Grenoble | Grenoble | Rhône-Alpes |
France | Georges Pompidou European Hospital | Paris | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Withings |
France,
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 |
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