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

COVID-19 Clinical Trial

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

Status Suspended

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Lower Respiratory Infection
• Respiration Disorders
• Respiratory Tract Diseases
• Respiratory Tract Infections
• Upper Respiratory Infection

• NCT number: NCT05035420
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Suspended
• Phase: N/A
• Start date: May 26, 2022
• Completion date: September 1, 2024