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Clinical Trial Summary

Background: The COVID-19 outbreak has strained the health care system. New tools are needed for diagnostic testing and monitoring of people who have the virus. Researchers want to test a device they hope can screen, detect, and monitor symptoms linked to respiratory diseases like COVID-19. Objective: To evaluate and validate a device that measures breathing, body temperature, heart rate, and tissue oxygenation. Eligibility: Healthy adults ages 18 and older with no flu-like symptoms and no current signs of infection, cough, fever, or sneezing. Design: Participants will have a physical exam. Their vital signs will be taken. Participants will sit in a chair. They will be monitored for 60 to 80 minutes while they do the following tasks: Rest for 10 minutes. They will repeat this after each task. Hold their breath for up to 2 minutes and then rest for 2 minutes. They will do this task 3 times. Pace-breathe with breathing rates of 10, 20, and 30 breaths per minute. They will do this task 2 times. Breathe air that has 5% of carbon dioxide for 5 minutes. During these tasks, data will be collected and recorded with a pulse oximeter, thermometer, respiratory belt, and spirometer. Participants will fill out questionnaires related to their daily activity (medication intake, exercise, smoking, and drinking). Participation will last for 2 to 3 hours.


Clinical Trial Description

The worldwide outbreak of novel Coronavirus Disease (COVID-19) has created a massive challenge for researchers and health professionals to increase testing capabilities and alleviate stress on the healthcare system. New tools are needed for diagnostic testing and monitoring under-treatment/observation patients who are infected by the virus. This challenge becomes more and more significant when one deals with geographical and economic disparities. Many commercial wearable devices including the Apple Watch, Fitbit, and Oura ring are all currently being studied for potential use in detecting early signs of viral infection. These devices, which can constantly monitor cardiovascular and respiratory metrics utilizing a PPG signal, may in the future be an important tool in monitoring disease onset, progression, and recovery. Most of these devices currently, however, do not assess oxygenation. Low oxygen saturation is another important parameter to consider for respiratory illness. Although pulse oximetry is commonly used to measure arterial tissue oxygenation, NIRS can capture oxygenation from the arteries, veins, capillaries and blood vessels, and is more sensitive to tissue perfusion. A single device capable of real-time, continuous monitoring of tissue oxygenation and respiratory function along with skin temperature may be able to offer an important assessment of the health, stability, and recovery of individuals sick with respiratory illness. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05035420
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact Kosar Khaksari, Ph.D.
Phone (301) 496-6786
Email [email protected]
Status Recruiting
Phase N/A
Start date September 22, 2021
Completion date September 1, 2022

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