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

NCT ID: NCT05823025

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-02

Study Completion Date

2024-11-02

Brief Summary

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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

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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.

Conditions

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Vascular Stiffness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypertension

Hypertensive patient

PWV measurement

Intervention Type OTHER

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)

PWV measurement

Intervention Type OTHER

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

Interventions

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PWV measurement

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Withings

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Boutouyrie, Pr

Role: PRINCIPAL_INVESTIGATOR

Georges Pompidou european hospital

Locations

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CHU Grenoble

Grenoble, Auvergne-Rhône-Alpes, France

Site Status

Georges Pompidou European Hospital

Paris, Île-de-France Region, France

Site Status

Countries

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France

Central Contacts

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Rui Yi YANG, PhD

Role: CONTACT

+33 6 19 78 25 54

Aline Criton, PhD

Role: CONTACT

+33 6 64 20 47 65

Facility Contacts

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Jean-Louis Pépin, Pr

Role: primary

+33 4 76 76 50 85

Pierre Boutouyrie, Pr

Role: primary

+33 1 56 09 39 91

Other Identifiers

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2022-A00776-37

Identifier Type: -

Identifier Source: org_study_id

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