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

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 26, 2022

Primary Completion Date

August 27, 2025

Study Completion Date

August 27, 2025

Conditions
COVID-19Upper Respiratory InfectionLower Respiratory Infection
Interventions
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.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

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

NIH