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

March 29, 2024 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Study Description:<TAB>

This observational pilot study will characterize the performance of a multimodal biosensor device (a portable and a wireless NIRS device, PPG and temperature sensor) in measuring human vital signs, which later will be explored as a point-of-care method for screening and treatment response monitoring of individuals with an infectious respiratory illness. The devices will measure heart, respiratory, and tissue oxygenation parameters in healthy subjects at rest and during induced hypercapnia, breath holding, and paced breathing.

Objectives:

<TAB>

Primary objective: Compare performance of two multimodal NIRS biosensor devices with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.

Secondary objective: 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.

Exploratory objective: Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations.

Endpoints:<TAB>

Primary endpoint: Paired differences, Lin s concordance correlation coefficient and Bland-Altman analysis for the following parameters: Biosensor tissue microvascular oxygenation level (StO2), respiratory rate (RR), respiratory effort index (REI), heart rate (HR) and heart rate variability (HRV).

Secondary endpoint: Paired differences, Lin s concordance correlation coefficient and Bland-Altman analysis for the following parameters: Biosensor tissue microvascular oxygenation level (StO2), respiratory rate (RR), respiratory effort index (REI), heart rate (HR) and heart rate variability (HRV) during induced hypercapnia, breath holding, and paced breathing exercises.

Exploratory endpoint: Arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2).

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

  • 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 (afebrile, temperature < 100.4 (Infinite) F) on the day of the experiment.

EXCLUSION CRITERIA:

  • Any skin disease.
  • Fever (Temperature greater than or equal to 100.4 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: End of study
Compare performance of two multimodal NIRS biosensor devices with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.
End of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations.
Time Frame: 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.
End of study
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.
Time Frame: End of study
Accuracy of the biosensor not only depends on comparison to baseline values but also should correlate during induced changes.
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 28, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210028
  • 21-CH-0028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

.We are working on deciding if we will share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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