NCT05178459已完成不适用
Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Withings
- 入组人数
- 177
- 试验地点
- 4
- 主要终点
- Sudomotor dysfunction diagnostic performance evaluation
研究概览
简要总结
The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.
详细描述
Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Sudomotor dysfunction diagnostic performance evaluation
时间窗: 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).
次要结局
- Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet.(10 months)
- Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires(10 months)
- Safety use of this device(10 months)
研究者
研究点 (4)
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