This study is NOT currently recruiting participants.
Number
21-CH-0028
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
No
Population Exclusion(s)
None
Keywords
point-of-care multimodal biosensing device; COVID-19 screening and monitoring
Recruitment Keyword(s)
Condition(s)
COVID-19; Upper respiratory Infection; Lower Respiratory Infection
Investigational Drug(s)
Investigational Device(s)
Intervention(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.
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.
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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
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
Principal Investigator
Referral Contact
For more information: