Noninvasive Biosensing Device for Respiratory Diseases

Overseen By Amir H Gandjbakhche, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Must not be taking: Nitrates, Sulfonamides, Narcotics, others

Disqualifiers: Cardiovascular, Pulmonary, Seizure, Smokers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Amir H Gandjbakhche, Ph.D.

Principal Investigator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria

This trial is for healthy adults over 18 with no current flu-like symptoms, coughs, fevers, or sneezing. Participants must be free of skin diseases, cardiovascular or pulmonary issues and not taking certain medications like nitrates that affect blood oxygen levels. Pregnant women and individuals with a history of seizures are excluded.

Inclusion Criteria

Provision of signed and dated informed consent form

I am in good health with no cough, sneeze, or cold symptoms.

Body temperature in normal range (afebrile, temperature < 100.4°F) on the day of the experiment

Exclusion Criteria

I have a history of seizures.

I have a known respiratory condition.

Unable or unwilling to give informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Monitoring and Data Collection

Participants are monitored for 60 to 80 minutes while performing various breathing tasks. Data is collected using a pulse oximeter, thermometer, respiratory belt, and spirometer.

2-3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the monitoring session

End of study

Treatment Details

Interventions

• BIOPAC
• Douglas Bag
• Fitbit
• Flowmet
• NIRS
• Periflux 6000 EPOS

Trial Overview Researchers are testing a new device designed to screen and monitor respiratory diseases by measuring breathing patterns, body temperature, heart rate, and tissue oxygenation during various controlled tasks such as breath-holding and paced-breathing.

Participant Groups

Group I: Healthy Volunteer Experimental Treatment 6 Interventions

Healthy Volunteer

Who Is Running the Clinical Trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Lead Sponsor

Trials

2,103

Recruited

2,760,000+