Testing of an Electronic Patch During Dehydration in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in impedance following mild dehydration
研究概览
简要总结
The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of Furosemide. In addition, the study will investigate changes in bioimpedance related to normal variation in tissue hydration (circadian changes, skin thickness, posture, and moderate activity). The study will also provide information on the durability of the sensor.
详细描述
The subjects will use the patches for ten days. During the ten-day period, subjects are exposed to an intervention on day 2 or 3 while being monitored by health personnel:
- Subjects are given a diuretic (Furosemide) and monitored for two hours without any intake.
- The intervention is followed by intake of a rehydration solution (up to 1500 ml), containing glucose and electrolytes (Resorb Sport, Nestle S.A.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI: 18-30
- •Age: 18-60
- •Willing to refrain from exercise for the duration of the study
- •Willing to refrain from bathing, swimming and other physical activity causing considerable sweating/movement (e.g. cycling, mountain hiking, climbing)
排除标准
- •Hypersensitivity to diuretics
- •Hypotension or orthostatic hypotension
- •Urinary retention
- •Pregnancy or breast feeding
- •Allergy to medical adhesive or gel
- •Any planned medical examination during the intervention period
- •Pacemaker
- •Use of medication with a significant impact on the body's fluid balance, such as diuretic
研究组 & 干预措施
Hydration sensor
The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3.
干预措施: Dehydration (Drug)
Hydration sensor
The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3.
干预措施: Rehydration (Dietary Supplement)
结局指标
主要结局
Change in impedance following mild dehydration
时间窗: 2 hours
Relative change in extracellular resistance measured by the investigational device following administration of Furosemide compared to control days
次要结局
- Change in impedance following rehydration(1 hour)