The Validation Study of Bioelectronics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of North Carolina, Chapel Hill
About this trial
The purpose of this study is to investigate the safe wearability and basic functions of the multi-modality sensors fabricated in the PI lab.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals with ages between 18 and 99.
Healthy individuals (not known to suffer any significant illness relevant to the proposed study).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Multi-modality Noninvasive Biosensor
DeviceThe 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
DeviceThe 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
DeviceThe 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
DeviceThe 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.
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Wearing Biosensor Before & After ExerciseExperimental treatment 4 interventions
Group B: Wearing Biosensor for an Extended PeriodExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Mean Comfort Level of Wearable Sensors
A questionnaire about the comfort of the wearable sensors will be measured using the Likert scale, which ranges from 1 to 5 and is used to measure attitudes and perception changes about the our sensor. The minimum value 1 represents "strongly disagree" and the maximum value 5 represents "strongly agree", thus higher scores represent a better outcome.
Time frame
Questionnaire completed within 96 hours after device application.2
Mean Safety Level of Wearable Sensors
A questionnaire about the safety and reactions to the wearable sensors will be measured using the Likert scale, which ranges from 1 to 5 and is used to measure attitudes and perception changes about the safety of our sensor. The minimum value 1 represents "strongly disagree" and the maximum value 5 represents "strongly agree", thus higher scores represent a better outcome.
Time frame
Questionnaire completed within 96 hours after device application.3
Mean Agreement Over Time of Physiological Parameters between Newly-Fabricated Wearable Sensors and Approved Devices
Signals from the approved medical devices will measure tissue mechanics, heart rate, respiration rate, blood flow, and pulse oxygenation measurements and these data will be compared to the signals from our sensors. The difference over time will be measured on a scale from a minimum of 0 and a maximum of 1, with 0 being the best outcome and representing the lowest difference between the sensing data from the different devices.
Time frame
Through study completion, an average of 15 minutes.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
North Carolina Translational and Clinical Sciences Institute
Collaborator
Source ClinicalTrials.gov