Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale

Neuropathy Clinical Trial

— WISUDO  

Official title:

Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05178459
• Other study ID #: 2021-A02624-37
• Status: Completed
• Start date: March 11, 2022
• Est. completion date: August 8, 2022

Study information

• Verified date: January 2023
• Source: Withings
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.

Description:

Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: August 8, 2022
• Est. primary completion date: July 22, 2022
• 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 type of patients are included in the study :
• Patients having diabetes (80% of the inclusion)
• Non diabetic patients having a lower limbs neuropathy (20% of the inclusion)

Exclusion Criteria:

• Minors under 18 years old
• Subject is pregnant or trying to get pregnant
• Subjects having a pacemaker
• 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 an lower limb amputation bigger than toes
• Individuals not able to stand still for a few minutes
• Individuals under antidepressant medications

Related Conditions & MeSH terms

• Neuropathy
• Peripheral Nervous System Diseases

Intervention

Diagnostic Test:
• Neuropathy measurement
Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.

Locations

Country	Name	City	State
France	Henri-Mondor Hospital	Créteil	Île De France
France	Bichat-Claude Bernard Hospital	Paris	Ile-de-France
France	Cochin Hospital	Paris	Île De France
France	Lariboisière Hospital	Paris	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Withings

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sudomotor dysfunction diagnostic performance evaluation	The diagnostic performance of the Withings WBS08 will be established using the sensitivity and the specificity for an electrochemical skin conductance threshold (moderate dysfunction and severe dysfunction).	10 months
Secondary	Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet.	The root-mean-square error (RMSE) and the mean absolute error (MAE) between the sudomotor function value measured by the Withings WBS08 and the Sudoscan as reference on each foot and by averagin g both feet.	10 months
Secondary	Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires	The correlation between diabetes neuropathy questionnair es and Withings WBS08.	10 months
Secondary	Safety use of this device	The rate of adverse effects.	10 months