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Development of Microfluidic Patch-type Sweat Sensor

NCT07342387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-01-15

No results posted yet for this study

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

OTHER

Time-course changes in Sodium and Creatinine levels.

Time-course changes in Sodium and Creatinine levels.

Sponsors & Collaborators

  • Korea University

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2024-12-20
Completion
2026-01-07

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342387 on ClinicalTrials.gov