A device for screening and monitoring respiratory diseases
A Pilot Study to Evaluate A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases
This study is testing a new device that checks vital signs to see if it can help monitor and screen for respiratory diseases like COVID-19 in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 78 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05035420 on ClinicalTrials.gov |
What this trial studies
This study evaluates a noninvasive multimodal biosensing device designed to screen and monitor responses to treatment for infectious respiratory diseases, including COVID-19. Participants will undergo a series of tasks while their vital signs, such as breathing, heart rate, and tissue oxygenation, are measured. The study aims to compare the performance of this new device against commercial systems in healthy adults without respiratory symptoms. The findings could pave the way for improved point-of-care diagnostics for respiratory infections.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 and older with no current signs of respiratory infection.
Not a fit: Patients with existing respiratory conditions or those exhibiting flu-like symptoms will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could enhance the early detection and monitoring of respiratory diseases, leading to better patient outcomes.
How similar studies have performed: Other studies have explored similar biosensing technologies, but this specific approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Amir Gandjbakhche, Ph.D. — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study coordinator: Amir Gandjbakhche, Ph.D.
- Email: gandjbaa@mail.nih.gov
- Phone: (301) 435-9235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.