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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended
Gender: Male & Female
Min Age: 18 Years
Max Age: 78 Years

Referral Letter Required


Population Exclusion(s)



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

Recruitment Keyword(s)



Upper respiratory Infection;
Lower Respiratory Infection

Investigational Drug(s)


Investigational Device(s)



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

Supporting Site

National Institute of Child Health and Human Development


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.


To evaluate and validate a device that measures breathing, body temperature, heart rate, and tissue oxygenation.


Healthy adults ages 18 and older with no flu-like symptoms and no current signs of infection, cough, fever, or sneezing.


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.

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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.


-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

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Principal Investigator

Referral Contact

For more information:

Amir Gandjbakhche, Ph.D.
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
Building 12A
Room 2003
12 South Drive
Bethesda, Maryland 20892
(301) 435-9235

Amir Gandjbakhche, Ph.D.
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
Building 12A
Room 2003
12 South Drive
Bethesda, Maryland 20892
(301) 435-9235

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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