Development of Microfluidic Patch-type Sweat Sensor Utilizing Surface-enhanced Raman Mechanism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Time-course changes in Sodium and Creatinine levels.
研究概览
简要总结
1. Background Value of Sweat: Sweat has gained significant attention as a key biomarker for diagnosing dehydration and renal dysfunction (e.g., uremia), as it contains essential indicators that reflect blood concentrations, such as electrolytes and metabolites (creatinine, urea).
Technical Transition: To overcome the limitations of conventional absorbent pads, such as contamination and evaporation, it is essential to develop flexible, wearable microfluidic devices that enable immediate collection and high-precision analysis.
Domestic and International Trends: While countries like the U.S. are already utilizing real-time IoT monitoring technologies in military and sports sectors, there is an urgent need in Korea to secure physiological data optimized for the Korean population and to establish a robust medical analysis system.
2. Objectives To develop a skin-interfaced microfluidic platform integrated with a SERS biosensor for high-sensitivity, real-time detection of Sodium and Creatinine to monitor dehydration and renal health.
3. Research Plan
- Subject Selection: Recruit and obtain informed consent from patients visiting the hospital with renal disease (creatinine levels 1.5 mg/dL or higher).
- Clinical Schedule: Conduct the clinical study on the subjects' scheduled routine blood test dates.
- Patch Attachment: Apply the sweat collection patch and a control absorption pad to 1-2 body areas (e.g., center of the chest, forehead).
- Sweat Induction: Induce sweating by having subjects wait in an electric thermal chamber for 30 minutes.
- Absorption Pad Collection: For the control pads (which cannot collect time-series data), attach two initially and retrieve them during the early stages of sweat secretion.
- Microfluidic Patch Collection: Measure the volume of sweat collected (~100 uL per subject) to calculate sweat loss, then seal and transport to the laboratory.
- Comparative Sample Processing: Measure the weight of absorption pads before/after use to determine fluid loss. Extract sweat samples (~500 uL per subject) into micro-tubes for transport.
- Contamination Control: Utilize dry ice and insulated coolers during transport to prevent sample degradation or contamination.
- Quantitative Analysis & Evaluation: Perform quantitative analysis of sodium and creatinine levels from both samples using the proposed SERS-based method and standard analytical tools (HPLC or LC-MS). Compare the changes in biomarkers and sweat loss over time to evaluate and summarize the hydration status and renal function patterns of each subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 19 years or older
- •Patients with renal disease and a blood (serum) creatinine level of 1.5 mg/dL or higher
排除标准
- •Subjects who do not provide consent to participate in this study
- •Subjects with a medical history of skin allergies related to patches/adhesives
研究组 & 干预措施
Experimental Group
Measurement of creatinine concentration in sweat using a microfluidic patch-based sweat sensor
干预措施: Time-course changes in Sodium and Creatinine levels. (Other)
结局指标
主要结局
Time-course changes in Sodium and Creatinine levels.
时间窗: enrollment day
Measurement on the day of enrollment (Visit 1), followed by study termination
次要结局
未报告次要终点
