NCT05397951

The Validation Study of Bioelectronics

Evaluation of Wearable Multi-modality Sensors for Monitoring Vital Signs

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed description

Members of this research team have developed innovative, wearable devices capable of being comfortably and continuously worn while recording diverse physiologic measurements. The purpose of this study is to validate the safe wearability and basic functions of the novel biocompatible electronic sensor that will allow continuous, non-invasive physiological measurements. This study aims to obtain preliminary data on the safety and functional aspects of the developed devices and compare it to approved medical equipments (including Abbott Medquip Oximeter, Omron blood pressure monitor, and Vicorder device for pulse wave velocity), which will pave the way for future study that focuses certain disease model. Participants will be randomly assigned to Condition A, and wear the devices before and after exercise for 15 minutes each time, or Condition B and wear the devices for 2 hours continuously. During their 1-hour or 2.5-hour lab visit, study participants will wear the biocompatible electronic sensors and three approved medical devices during a slow deep breath, before and after a 6-minute brisk walk, or for an extended period of time (2 hours). Participants will return to the lab for two brief visits, 48 and 96 hours after the device wearing, to determine if any suspected adverse events related to study procedures or devices emerged after they left the research site. For the future study, we will plan to 1) optimize the devices for use in patients needing FiO2 weaning, 2) demonstrate the reliability, and accuracy of these devices for continuous physiological measurements, including but not limited to blood pressure, heart rate (HR), cerebral blood flow, temperature, glucose concentration, and respiratory rate, and 3) demonstrate these devices are preferred by patients to current measurement tools. Once validated, such sensors could fundamentally change the way blood flow, blood pressure, or related parameters are monitored for patients, eliminating risks associated with invasive monitoring, allowing continuous, real-time detection of clinically meaningful changes in the patients, advancing knowledge of hormonal signatures and physiological signals preceding clinically meaningful events.

Conditions

• Healthy
• Health Behavior

Interventions

Type	Name	Description
DEVICE	Multi-modality Noninvasive Biosensor	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.
DEVICE	Oximeter	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.
DEVICE	Portable Blood Pressure Monitor	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.
DEVICE	Vicorder Pulse Wave Velocity Monitor	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.

Timeline

• Start date: 2024-01-09
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-05-31
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study