Noninvasive Biosensing Device for Respiratory Diseases

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Overseen ByAmir H Gandjbakhche, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

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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

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
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Exclusion Criteria

I have a history of seizures.
I have a known respiratory condition.
Unable or unwilling to give informed consent
See 8 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Healthy VolunteerExperimental Treatment6 Interventions

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

Trials
2,103
Recruited
2,760,000+

Citations

Indoor air sampling for detection of viral nucleic acidsThis review provides a comprehensive examination of indoor air sampling for viral nucleic acid detection, focusing on the sources and composition of viruses ...
PeriFlux 6000 Enhanced Perfusion and Oxygen SystemPeriFlux 6000 EPOS is designed for use in clinical studies, addressing the need for robust microcirculation measurements.
An integrated cell atlas of the lung in health and disease - PMCIn this resource, we present an integrated single-cell transcriptomic atlas of the human respiratory system, including the upper and lower airways, from ...
Polymer Materials for Respiratory Protection: Processing, End ...The present review describes the most relevant literature studies on materials and processing technologies used for facemask development and testing.
Study Details | NCT01249625 | The Respiratory Protection ...The study outcomes are to: determine the most effective FPE equipment to use to prevent disease transmission in the OPD during an influenza outbreak, epidemic ...
510(k) Summary - accessdata.fda.govThe PeriFlux 6000 simply follows the state of the art in standards and available technology to create a safe, effective and convenient device.
Health Effects of Occupational Exposure to Silver ...Adverse health effects of nanoscale silver particles, such as early stage lung inflammation and liver hyperplasia, have been observed in rats fol- lowing ...
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