The Validation Study of Bioelectronics
Evaluation of Wearable Multi-modality Sensors for Monitoring Vital Signs
University of North Carolina, Chapel Hill
22 participants
Jan 9, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Individuals with ages between 18 and 99.
- Healthy individuals (not known to suffer any significant illness relevant to the proposed study).
Exclusion Criteria6
- 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.
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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.
Locations(1)
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NCT05397951