A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT05035420
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
10.4
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Fitbit
  • Device: Douglas Bag
  • Device: Periflux 6000 EPOS
  • Device: BIOPAC
  • Device: Flowmet
  • Device: NIRS
N/A

Detailed 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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
A Pilot Study to Evaluate a Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases
Anticipated Study Start Date :
Oct 20, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Healthy Volunteer

Healthy Volunteer

Device: Fitbit
Performance of the NIRS biosensor will be explored in comparison to this commercial wearable.

Device: Douglas Bag
The Douglas Bag will be used for inducing hypercapnia.

Device: Periflux 6000 EPOS
Tissue oxygen saturation measured by the Periflux 6000 will be compared with peripheral tissue saturation measured with the NIRS biosensor both at rest and during the induced hypercapnia, paced breathing and breath holding.

Device: BIOPAC
The BIOPAC system will be used to record the PPG signal, cardiovascular hemodynamics, and respiratory parameters in order to noninvasively monitor the heart rate, heart rate variability, respiratory rate, respiratory effort index, and arterial oxygen saturation.

Device: Flowmet
Flowmet will be used for a measurement of arterial blood flow within the finger or toe. Flowmet outputs a PPG waveform that will be compared with the NIRS biosensor.

Device: NIRS
a. Each subject will be monitored with the multimodal system for 10 minutes while sitting quiescent on a chair in resting position. All screening index parameters will be collected and recorded. b. Each subject will be studied for approximately 60-80 minutes while being exposed to a mild Hypercapnia (5% CO2), paced breathing and breath holding followed by a 10-minute recovery time after each task.

Outcome Measures

Primary Outcome Measures

  1. Compare performance of a multimodal biosensor device with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest. [End of study]

    Development of an accurate point-of-care device capable of measuring multiple vascular and respiratory parameters could be of use for screening and monitoring of infectious respiratory disease

Secondary Outcome Measures

  1. Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations. [End of study]

    We would like to know if arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) are also sensitive to respiratory changes. Although these parameters are all related, they may exhibit unique behavior due to autoregulatory mechanisms in the brain and differences between arterial and tissue saturation.

  2. Compare measured changes in cardiac, respiratory, and tissue oxygenation parameters during induced hypercapnia, breath holding, and paced breathing exercises between the biosensor and commercial systems. [End of study]

    Accuracy of the biosensor not only depends on comparison to baseline values but also should correlate during induced changes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Provision of signed and dated informed consent form.

  • Stated willingness to comply with all study procedures and availability for the duration of the study.

  • Male or female aged 18 years or greater.

  • In good general health as evidenced by medical history with no signs of cough, sneeze and upper respiratory symptoms.

  • Body temperature in normal range (97 degrees - 99 degrees F) on the day of the experiment.

EXCLUSION CRITERIA:
  • Any skin disease.

  • Fever (temperature above 99 degrees F).

  • Any past or present cardiovascular or pulmonary diseases.

  • Known adverse reaction to latex.

  • Any medical condition that, in the opinion of the Principal Investigator would preclude the inclusion of a patient onto this research study.

  • Unable or unwilling to give informed consent.

  • Individuals with known respiratory conditions.

  • Individuals who are currently taking medication that may cause methemoglobinemia such as nitrates derivatives, sulfonamides, dapsone, phenacetin, phenazopyridine, some local anesthetics such as prilocaine, topical anesthetics such as emla cream, benzocaine.

  • Individuals with history of seizure.

  • Smokers and those on narcotics.

  • Pregnant women are excluded due to risk associated to hypercapnia risk

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1National Institutes of Health Clinical CenterBethesdaMarylandUnited States20892

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Amir Gandjbakhche, Ph.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT05035420
Other Study ID Numbers:
  • 210028
  • 21-CH-0028
First Posted:
Sep 5, 2021
Last Update Posted:
Oct 15, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021