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

NCT05035420 | Completed

• 2 other identifiers: 21002821-CH-0028
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Upper Respiratory Infection; Lower Respiratory Infection

Keywords

point-of-care multimodal biosensing device; COVID-19 screening and monitoring

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (2)

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

  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.

  End of study

Study Arms (1)

Healthy Volunteer

EXPERIMENTAL

Healthy Volunteer

Device: Fitbit; Device: Douglas Bag; Device: Periflux 6000 EPOS; Device: BIOPAC; Device: Flowmet; Device: NIRS

Interventions

Fitbit DEVICE

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

Healthy Volunteer

Douglas Bag DEVICE

The Douglas Bag will be used for inducing hypercapnia.

Healthy Volunteer

Periflux 6000 EPOS DEVICE

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.

Healthy Volunteer

BIOPAC DEVICE

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.

Healthy Volunteer

Flowmet DEVICE

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.

Healthy Volunteer

NIRS DEVICE

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.

Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Sakudo A. Near-infrared spectroscopy for medical applications: Current status and future perspectives. Clin Chim Acta. 2016 Apr 1;455:181-8. doi: 10.1016/j.cca.2016.02.009. Epub 2016 Feb 12.

  PMID: 26877058 BACKGROUND

• Chiu WT, Lin PW, Chiou HY, Lee WS, Lee CN, Yang YY, Lee HM, Hsieh MS, Hu CJ, Ho YS, Deng WP, Hsu CY. Infrared thermography to mass-screen suspected SARS patients with fever. Asia Pac J Public Health. 2005;17(1):26-8. doi: 10.1177/101053950501700107.

  PMID: 16044829 BACKGROUND

• Abay TY, Kyriacou PA. Reflectance Photoplethysmography as Noninvasive Monitoring of Tissue Blood Perfusion. IEEE Trans Biomed Eng. 2015 Sep;62(9):2187-95. doi: 10.1109/TBME.2015.2417863. Epub 2015 Mar 30.

  PMID: 25838515 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Amir H Gandjbakhche, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 5, 2021
• Study Start: May 26, 2022
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-09-03

Locations

US (1)