Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- The determination of ethanol in the plasma
研究概览
简要总结
A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine the presence of vapor of alcohol in insensible perspiration.
One of possible application would be a continuous and non invasive monitoring of drinking behavior. To investigate the validity of this method, it's necessary to compare Transdermal Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations and breath Alcohol Concentrations provided by reference methods.
The purpose of this study is to identify the kinetic of alcohol concentration in blood, exhaled air and sweat after alcohol ingestion.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18-40 years, age-matched (+ 3 years)
- •Caucasian
- •BMI: 19 to 28 kg/m2
- •No smoking or light smoker (<5 cig/d)
- •Moderate consumer of alcohol (3-14 drinks/week), with the intoxicated experience
排除标准
- •Subjects with addiction to toxic or alcohol (MINI Questionnaire)
- •Positive individuals in search of drugs and toxic
- •Anxiety or depressive subjects (IASTA Questionnaires and BDI)
研究组 & 干预措施
healthy volunteers
干预措施: oral dose of alcohol (Other)
healthy volunteers
干预措施: alcotest (Device)
healthy volunteers
干预措施: blood samples (Biological)
healthy volunteers
干预措施: Transdermal monitor (Device)
结局指标
主要结局
The determination of ethanol in the plasma
时间窗: 6 months
blood samples
次要结局
- measures in the exhaled air(6 months)
- sweat alcohol concentration(6 months)