Development of Microfluidic Patch-type Sweat Sensor

NCT07342387 | Completed

• 1 other identifier: 2024AN0368
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Clinical Schedule: Conduct the clinical study on the subjects' scheduled routine blood test dates.
3. 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. 4.Sweat Induction: Induce sweating by having subjects wait in an electric thermal chamber for 30 minutes.
5. 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. 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. 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. 8.Contamination Control: Utilize dry ice and insulated coolers during transport to prevent sample degradation or contamination.
9. 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

Outcome Measures

Primary Outcomes (1)

• Time-course changes in Sodium and Creatinine levels.

  Measurement on the day of enrollment (Visit 1), followed by study termination

  enrollment day

Study Arms (1)

Experimental Group

EXPERIMENTAL

Measurement of creatinine concentration in sweat using a microfluidic patch-based sweat sensor

Other: Time-course changes in Sodium and Creatinine levels.

Interventions

Time-course changes in Sodium and Creatinine levels. OTHER

Time-course changes in Sodium and Creatinine levels.

Experimental Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 19 years or older
• Patients with renal disease and a blood (serum) creatinine level of 1.5 mg/dL or higher

You may not qualify if:

• Subjects who do not provide consent to participate in this study
• Subjects with a medical history of skin allergies related to patches/adhesives

Sponsors & Collaborators

• Korea University: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

Location

MeSH Terms

Conditions

Urogenital Diseases

Interventions

Sodium

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 15, 2026
• Study Start: June 15, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 7, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)