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

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Sep 3, 2021

Keywords

ClinConnect Summary

This clinical trial is testing a new, noninvasive device designed to help screen and monitor respiratory diseases, including COVID-19 and other infections that affect the lungs. The goal is to see if this device can accurately measure important health indicators like breathing, body temperature, heart rate, and oxygen levels in the body. By doing this, researchers hope to find a better way to detect and track respiratory illnesses, which have become increasingly important during the COVID-19 pandemic.

To participate in this study, you need to be a healthy adult aged 18 or older with no signs of illness, such as fever, cough, or sneezing. If you join, you will undergo a physical exam and be monitored for about 2 to 3 hours while you perform simple breathing tasks. During this time, your vital signs will be recorded using various devices, and you’ll also fill out some questionnaires about your daily activities. The trial is currently recruiting participants, and it’s important to note that certain medical conditions, like respiratory diseases or a history of seizures, will prevent you from taking part.

Gender

ALL

Eligibility criteria

• * 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