Validation Study of Wearable Bioelectronic Sensors
This study is testing new, comfortable wearable sensors developed in a lab. These sensors, called Multi-modality Noninvasive Biosensors, are designed to continuously measure things like your heart rate, breathing, and blood flow. Researchers want to see if these new sensors are safe to wear and if they work as well as standard medical devices like an oximeter, a portable blood pressure monitor, and a Vicorder Pulse Wave Velocity Monitor. You can join if you are a healthy adult between 18 and 99 years old. The study aims to understand how comfortable and safe the new sensors are, and how well their measurements match those from approved devices. The current status of the study is unclear.
- Study design
- This interventional study plans to enroll 22 healthy participants. You will be randomly assigned to wear the devices for either 15 minutes before and after exercise, or for 2 hours continuously.
- What's involved
- You will have a 1-hour or 2.5-hour lab visit where you wear the sensors during activities like slow deep breathing and a brisk walk. You will also return for two brief follow-up visits 48 and 96 hours after wearing the devices.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have follow-up visits 48 and 96 hours after wearing the devices to check for any side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Validation Study of Bioelectronics
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Wubin Bai, PhD · PRINCIPAL_INVESTIGATOR · Assistant Professor of Applied Physical Sciences
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Mean Comfort Level of Wearable SensorsQuestionnaire completed within 96 hours after device application.
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.
- Mean Safety Level of Wearable SensorsQuestionnaire completed within 96 hours after device application.
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.
- Mean Agreement Over Time of Physiological Parameters between Newly-Fabricated Wearable Sensors and Approved DevicesThrough study completion, an average of 15 minutes.
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.