The Validation Study of Bioelectronics
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About
The purpose of this study is to investigate the safe wearability and basic functions of the multi-modality sensors fabricated in the PI lab.
Full 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.
Enrollment
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
22 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Hannah L Weisbecker, BS; Wubin Bai, PhD
Data sourced from clinicaltrials.gov
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