Status:
RECRUITING
The Validation Study of Bioelectronics
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
North Carolina Translational and Clinical Sciences Institute
Conditions:
Healthy
Health Behavior
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the safe wearability and basic functions of the multi-modality sensors fabricated in the PI lab.
Detailed Description
Members of this research team have developed innovative, wearable devices capable of being comfortably and continuously worn while recording diverse physiologic measurements. The purpose of this study...
Eligibility Criteria
Inclusion
- Individuals with ages between 18 and 99.
- Healthy individuals (not known to suffer any significant illness relevant to the proposed study).
Exclusion
- Pregnant or lactating.
- History of active (clinically significant) skin disorders that make skin vulnerable to contact conventional electronic devices.
- History of allergic response to silicones or adhesives (such as 3M Tegaderm).
- Broken, damaged or irritated skin or rashes near the sensor application sites (finger, wrist, temple, subclavian, arm, neck, and thigh).
- Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator to ensure safe completion of study tasks.
- Subjects who are unable to participate in moderate exercise for 6 minutes.
Key Trial Info
Start Date :
January 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05397951
Start Date
January 9 2024
End Date
November 1 2025
Last Update
September 22 2025
Active Locations (1)
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1
Kenan Laboratories at the University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514