Withings Study to Analyze the Accuracy of Pulse Wave Velocity Measurement With Bathroom Scales
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Withings
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- PWV measurement deviation
研究概览
简要总结
The aim of this study is to evaluate the diagnostic performance of Withings bathroom scales WBS08 and WBS12 to measure PWV (Pulse Wave Velocity).
详细描述
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.
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 subsets of patients will be included in the study :
- •Hypertensive patient
- •Patient having sleep apnea or COPD (Chronic obstructive pulmonary disease)
排除标准
- •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.
研究组 & 干预措施
Hypertension
Hypertensive patient
干预措施: PWV measurement (Other)
Sleep apnea or COPD
Patient having sleep apnea or COPD (Chronic obstructive pulmonary disease)
干预措施: PWV measurement (Other)
结局指标
主要结局
PWV measurement deviation
时间窗: 1 year
The standard deviation of the difference between the PWV measured and the PWV reference (m.s-1)
PWV measurement bias
时间窗: 1 year
Difference between the PWV measured and the PWV reference (m.s-1)
次要结局
- Safety use(1 year)