The Validation Study of Bioelectronics
Evaluation of Wearable Multi-modality Sensors for Monitoring Vital Signs
2 other identifiers
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jan 2024
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
January 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
April 17, 2026
April 1, 2026
2.8 years
May 19, 2022
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Questionnaire completed within 96 hours after device application.
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.
Questionnaire completed within 96 hours after device application.
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.
Through study completion, an average of 15 minutes.
Study Arms (2)
Wearing Biosensor Before & After Exercise
EXPERIMENTALEach 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.
Wearing Biosensor for an Extended Period
EXPERIMENTALEach study participant will wear the bioelectronic sensors during a slow deep breath. Participants will wear the sensors and devices continuously for 2 hours.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Individuals with ages between 18 and 99.
- Healthy individuals (not known to suffer any significant illness relevant to the proposed study).
You may not qualify if:
- 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).
- Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator to ensure safe completion of study tasks.
- Subjects who are unable to participate in moderate exercise for 6 minutes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kenan Laboratories at the University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wubin Bai, PhD
Assistant Professor of Applied Physical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2022
First Posted
May 31, 2022
Study Start
January 9, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 9 and continuing for 36 months following publication.
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.
Deidentified individual data that supports the results may be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.