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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05823025
Other study ID # 2022-A00776-37
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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