NCT05831800招募中不适用
Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals - A Prospective Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean use time of the wearable sensor
研究概览
简要总结
This is a single-arm prospective study, investigating the feasibility, usability, and safety of a wearable bioimpedance sensor in elderly individuals. The sensor is applied on the upper back of the subject, and will be replaced once weekly. The study will include four phases, each interspersed by an interim analysis. Each phase will have a duration of four weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 60 years
排除标准
- •Known allergies or skin sensitivities to electrode hydrogel and/or acrylic-based adhesives
- •Non-intact skin such as skin breakdown where the device is to be placed (upper back)
- •Implantable pulse generators such as pacemakers and defibrillators
- •Any medical or psychiatric condition, which in the opinion of the investigator precludes participation
结局指标
主要结局
Mean use time of the wearable sensor
时间窗: Up to 7 days
次要结局
- Clinical assessment of hydration status(Day 1, 8, 15, 22, 29)
- The mean number of days the sensor provides valid measurements(Up to 7 days)
- Frequency and severity of adverse device effects(Day 1-30)
- Stability of device measurements following weekly patch replacement(Day 8, 15, 22, 29)
- Mean and standard deviation of the device output variables(Up to 7 days)
- User satisfaction(Day 8, 15, 22, 29)
研究者
研究点 (1)
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