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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up questionnaire completed within 96 hours after device application.
Awards & highlights
No Placebo-Only Group

Study 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.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,486 Previous Clinical Trials
4,153,822 Total Patients Enrolled
North Carolina Translational and Clinical Sciences InstituteOTHER
55 Previous Clinical Trials
4,263 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this research project?

"Affirmative. According to information on clinicaltrials.gov, the trial was originally posted on June 1st 2022 and is actively enrolling patients. A total of 12 participants are needed from one site for this study."

Answered by AI

Are seniors being considered as part of the patient pool for this clinical evaluation?

"According to the trial's admissions requirements, only those aged between 18 and 65 are suitable for enrollment. In comparison, there are 75 studies recruiting patients below legal age and 423 trials targeting seniors over 65 years old."

Answered by AI

Who is the most suitable candidate for participating in this trial?

"This medical investigation is currently recruiting a dozen individuals between 18 and 65, who generally maintain good health. In order to qualify for this trial, the candidate must not have any pre-existing conditions that could impact the research results and should be either male or female."

Answered by AI

What is the cap on participants for this research endeavor?

"Affirmative, the data hosted on clinicaltrials.gov confirms that this medical study is actively seeking participants. Initially posted on June 1st 2022 and recently updated on October 17th, it requires 12 patients to be recruited from one site."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Kenan Laboratories at the University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Mar 2024