NCT07342387

Development of Microfluidic Patch-type Sweat Sensor

Development of Microfluidic Patch-type Sweat Sensor Utilizing Surface-enhanced Raman Mechanism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Korea University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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 1. Subject Selection: Recruit and obtain informed consent from patients visiting the hospital with renal disease (creatinine levels 1.5 mg/dL or higher). 2. Clinical Schedule: Conduct the clinical study on the subjects' scheduled routine blood test dates. 3. Patch Attachment: Apply the sweat collection patch and a control absorption pad to 1-2 body areas (e.g., center of the chest, forehead). 4. Sweat Induction: Induce sweating by having subjects wait in an electric thermal chamber for 30 minutes. 5. 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. 6. Microfluidic Patch Collection: Measure the volume of sweat collected (\~100 uL per subject) to calculate sweat loss, then seal and transport to the laboratory. 7. 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. 8. Contamination Control: Utilize dry ice and insulated coolers during transport to prevent sample degradation or contamination. 9. 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.

Conditions

• Diseases of the Genitourinary System

Interventions

Type	Name	Description
OTHER	Time-course changes in Sodium and Creatinine levels.	Time-course changes in Sodium and Creatinine levels.

Timeline

• Start date: 2024-06-15
• Primary completion: 2024-12-20
• Completion: 2026-01-07
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: South Korea