The Validation Study of Bioelectronics

Official title

Evaluation of Wearable Multi-modality Sensors for Monitoring Vital Signs

Overview

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.

Interventions

• 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.

Primary outcome measures

• Mean Comfort Level of Wearable Sensors [Time frame: Questionnaire completed within 96 hours after device application.]
• Mean Safety Level of Wearable Sensors [Time frame: Questionnaire completed within 96 hours after device application.]
• Mean Agreement Over Time of Physiological Parameters between Newly-Fabricated Wearable Sensors and Approved Devices [Time frame: Through study completion, an average of 15 minutes.]

Eligibility criteria

Inclusion criteria

• Individuals with ages between 18 and 99.
• Healthy individuals (not known to suffer any significant illness relevant to the proposed study).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

United States · 1 center

• Kenan Laboratories at the University of North Carolina at Chapel Hill — Chapel Hill

Identifiers

NCT: NCT05397951 · 22-0163 · 550KR272101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗