The Validation Study of Bioelectronics

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05397951
Status
Recruiting
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Conditions

  • Health Behavior
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Multi-modality Noninvasive Biosensor — DEVICE
    The wearable sensor devices will be placed on the finger, wrist, temple, subclavian, arm, neck, and thigh of the participant and will provide continuous tissue mechanics, heart rate, respiration rate, blood flow, and pulse oxygenation measurements continuously throughout the experimental period.
  • Oximeter — DEVICE
    The oximeter device will be placed on the right middle finger of the participant and will provide continuous pulse oxygenation and heart rate measurements continuously throughout the experimental period.
  • Portable Blood Pressure Monitor — DEVICE
    The blood pressure monitor device will be placed on the left arm of the participant and will take a blood pressure measurement every 5 minutes throughout the 15 minute experimental period, and every 15 minutes throughout the 2 hour experimental period.
  • Vicorder Pulse Wave Velocity Monitor — DEVICE
    The pulse wave velocity monitor device will be placed on the right side of the neck and the right thigh and will provide measurements continuously throughout the experimental period.

Study Details

The purpose of this study is to investigate the safe wearability and basic functions of the multi-modality sensors fabricated in the PI lab.

Key Dates

Start date
Jan 9, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Wearing Biosensor Before & After Exercise
    Each study participant will wear the bioelectronic sensors during a slow deep breath. Participants will wear the sensors and devices for 15 minutes before and after a brisk 6-minute walk.
  • Experimental: Wearing Biosensor for an Extended Period
    Each study participant will wear the bioelectronic sensors during a slow deep breath. Participants will wear the sensors and devices continuously for 2 hours.

Primary Outcome Measure

Mean Comfort Level of Wearable Sensors [ Time Frame: Questionnaire completed within 96 hours after device application. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kenan Laboratories at the University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Hannah L Weisbecker, BS
[email protected]
678-641-7484
Wubin Bai, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Kenan Laboratories at the University of North Carolina at Chapel Hill· Chapel Hill, NC

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