Noninvasive Biosensing Device for Respiratory Diseases
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after the monitoring session
Treatment Details
Interventions
- BIOPAC
- Douglas Bag
- Fitbit
- Flowmet
- NIRS
- Periflux 6000 EPOS
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead Sponsor