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Bioelectronics Validation in Healthy Subjects

N/A
Recruiting
Led By Wubin Bai, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy individuals (not known to suffer any significant illness relevant to the proposed study)
Be older than 18 years old
Must not have
Broken, damaged or irritated skin or rashes near the sensor application sites (finger, wrist, temple, subclavian, arm, neck, and thigh)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up questionnaire completed within 96 hours after device application.
Awards & highlights

Summary

This trial is to study if it's safe and how well a new type of sensor works.

Who is the study for?
This trial is for healthy men and women aged between 18 and 65 who don't have any significant illnesses. It's not suitable for those unable to do daily activities normally, with active skin disorders, allergies to silicones or adhesives, or damaged skin near where sensors would be placed.Check my eligibility
What is being tested?
The study tests the safety and basic functions of new multi-modality biosensors designed in the lab. Participants will wear devices like a Vicorder Pulse Wave Velocity Monitor, an Oximeter, and a Portable Blood Pressure Monitor.See study design
What are the potential side effects?
Since this trial involves noninvasive monitoring devices, side effects are minimal but may include discomfort at the sensor sites or potential skin irritation from prolonged device contact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am generally healthy with no significant illnesses.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have broken or irritated skin where a sensor might be placed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~questionnaire completed within 96 hours after device application.
This trial's timeline: 3 weeks for screening, Varies for treatment, and questionnaire completed within 96 hours after device application. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Agreement Over Time of Physiological Parameters between Newly-Fabricated Wearable Sensors and Approved Devices
Mean Comfort Level of Wearable Sensors
Mean Safety Level of Wearable Sensors

Trial Design

2Treatment groups
Experimental Treatment
Group I: Wearing Biosensor for an Extended PeriodExperimental Treatment4 Interventions
Each study participant will wear the bioelectronic sensors during a slow deep breath. Participants will wear the sensors and devices continuously for 2 hours.
Group II: Wearing Biosensor Before & After ExerciseExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oximeter
2018
N/A
~20

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,526 Previous Clinical Trials
4,197,215 Total Patients Enrolled
North Carolina Translational and Clinical Sciences InstituteOTHER
57 Previous Clinical Trials
4,341 Total Patients Enrolled
Wubin Bai, PhDPrincipal InvestigatorAssistant Professor of Applied Physical Sciences

Media Library

Healthy Subjects Clinical Trial 2023: Multi-modality Noninvasive Biosensor Highlights & Side Effects. Trial Name: NCT05397951 — N/A
~15 spots leftby Jul 2025
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