Noninvasive Biosensing Device for Respiratory Diseases
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new device designed to detect and monitor respiratory diseases like COVID-19. The researchers seek to determine if the device can accurately measure breathing, body temperature, heart rate, and blood oxygen levels. Participants will perform a series of simple tasks while their vital signs are monitored. Healthy adults without current signs of infection, such as cough or fever, are ideal candidates for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could advance respiratory health monitoring.
Do I need to stop taking my current medications to join the trial?
You may need to stop taking certain medications if they can cause methemoglobinemia, such as nitrates, sulfonamides, and some anesthetics. If you're on these medications, you might not be eligible to participate.
What prior data suggests that this device is safe for monitoring respiratory diseases?
Research has shown that the PeriFlux 6000 EPOS device, used in this study, is safe and effective. This device is already employed in clinical studies to measure blood flow and oxygen levels noninvasively. It meets high safety standards and incorporates the latest technology.
These devices are easy to tolerate because they remain outside the body. They monitor vital signs like heart rate and breathing externally. The study involves healthy volunteers, focusing on safety and monitoring rather than treatment.
In summary, the devices tested are generally safe and noninvasive. They are designed to measure health indicators without causing discomfort.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores noninvasive biosensing devices for monitoring respiratory diseases, providing a fresh approach compared to traditional diagnostic methods like spirometry or blood tests. These devices, including BIOPAC and Fitbit, offer continuous, real-time tracking of respiratory parameters without the need for invasive procedures. This innovation could lead to more personalized and timely interventions, potentially improving outcomes for patients with respiratory conditions. By utilizing advanced technology like NIRS (Near-Infrared Spectroscopy) and Periflux 6000 EPOS, the trial aims to enhance the precision and convenience of respiratory health monitoring.
What evidence suggests that this device is effective for respiratory diseases?
Research has shown that noninvasive devices like the PeriFlux 6000 hold promise for checking vital signs and oxygen levels in the body. The PeriFlux 6000 accurately measures blood and oxygen flow, which is crucial for assessing overall health. This capability aids in monitoring breathing problems such as COVID-19. These devices offer a reliable method to track symptoms without invasive procedures. Early findings suggest they effectively help manage breathing issues by providing real-time information.14567
Who Is on the Research Team?
Amir H Gandjbakhche, Ph.D.
Principal Investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- BIOPAC
- Douglas Bag
- Fitbit
- Flowmet
- NIRS
- Periflux 6000 EPOS
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Who Is Running the Clinical Trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead Sponsor