WISUDO: Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale
Study Details
Study Description
Brief Summary
The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Diabetic Patient diagnosed with diabetes |
Diagnostic Test: Neuropathy measurement
Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.
|
| Neuropathic without diabetes Patient diagnosed with neuropathy without diabetes |
Diagnostic Test: Neuropathy measurement
Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.
|
Outcome Measures
Primary Outcome Measures
- Sudomotor dysfunction diagnostic performance evaluation [10 months]
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).
Secondary Outcome Measures
- Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet. [10 months]
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.
- Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires [10 months]
The correlation between diabetes neuropathy questionnair es and Withings WBS08.
- Safety use of this device [10 months]
The rate of adverse effects.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The subject is an adult, man or woman (18 years old or more)
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Subjects affiliated or eligible to a social security system
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Subjects having expressed their consent to take part in the study
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Two type of patients are included in the study :
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Patients having diabetes (80% of the inclusion)
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Non diabetic patients having a lower limbs neuropathy (20% of the inclusion)
Exclusion Criteria:
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Minors under 18 years old
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Subject is pregnant or trying to get pregnant
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Subjects having a pacemaker
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Subjects having refused to give their consent
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Vulnerable subjects according to the French regulation in force:
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Individuals deprived of liberty by a court, medical or administrative order
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Individuals legally protected or unable to express their consent to take part in the study
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Individuals unaffiliated to or not beneficiary of a social security system
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Individuals who fit in multiple categories above
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Individuals linguistically or mentally unable to express their consent
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Individuals having an lower limb amputation bigger than toes
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Individuals not able to stand still for a few minutes
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Individuals under antidepressant medications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bichat-Claude Bernard Hospital | Paris | Ile-de-France | France | 75018 |
| 2 | Henri-Mondor Hospital | Créteil | Île De France | France | 94000 |
| 3 | Cochin Hospital | Paris | Île De France | France | 75014 |
| 4 | Lariboisière Hospital | Paris | Île-de-France | France | 75010 |
Sponsors and Collaborators
- Withings
Investigators
- Principal Investigator: Louis Potier, Dr, Bichat-Claude Bernard Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-A02624-37