The Validation Study of Bioelectronics

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.

Conditions

• Healthy
• Health Behavior

Interventions

DEVICE

Multi-modality Noninvasive Biosensor

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.

DEVICE

Oximeter

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.

DEVICE

Portable Blood Pressure Monitor

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.

DEVICE

Vicorder Pulse Wave Velocity Monitor

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.

Sponsors & Collaborators

• North Carolina Translational and Clinical Sciences Institute

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Wubin Bai, PhD · Assistant Professor of Applied Physical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-09

Primary Completion

2026-11-30

Completion

2026-11-30

FDA Device

Yes

Countries

• United States

Study Locations