Study Summary
This trial is testing a device that could help screen, detect, and monitor symptoms linked to respiratory diseases like COVID-19. The device measures breathing, body temperature, heart rate, and tissue oxygenation.
Eligible Conditions
- Coronavirus
- Common Cold
- Bronchitis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: End of study
End of study
Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations.
Compare measured changes in cardiac, respiratory, and tissue oxygenation parameters during induced hypercapnia, breath holding, and paced breathing exercises between the biosensor and commercial systems.
Compare performance of a multimodal biosensor device with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Healthy Volunteer
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: Fitbit · No Placebo Group · N/A
Healthy VolunteerExperimental Group · 6 Interventions: Periflux 6000 EPOS, Douglas Bag, Fitbit, BIOPAC, Flowmet, NIRS · Intervention Types: Device, Device, Device, Device, Device, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fitbit
2018
N/A
~3440
NIRS
2013
N/A
~1080
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: end of study
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,824 Previous Clinical Trials
2,249,383 Total Patients Enrolled
Amir Gandjbakhche, Ph.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6 Previous Clinical Trials
482 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The body temperature was within the normal range on the day of the experiment.
The study participant must provide a signed and dated informed consent form in order to participate in the study.
I am willing to comply with all study procedures and be available for the duration of the study.
People aged 18 years or older, whether they are male or female.
The person is generally in good health and does not have any signs of a cough, sneeze, or upper respiratory symptoms.
Who else is applying?
What state do they live in?
| District of Columbia | 40.0% |
| Florida | 40.0% |
| Texas | 20.0% |
How old are they?
| 65+ | 50.0% |
| 18 - 65 | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
What site did they apply to?
| National Institutes of Health Clinical Center | 100.0% |
References
- Sakudo, Akikazu. 2016. “Near-infrared Spectroscopy for Medical Applications: Current Status and Future Perspectives”. Clinica Chimica Acta. Elsevier BV. doi:10.1016/j.cca.2016.02.009.
- Chiu, WT, PW Lin, H.Y. Chiou, W.S. Lee, C.N. Lee, Y.Y. Yang, H.M. Lee, et al.. 2005. “Infrared Thermography to Mass-screen Suspected Sars Patients with Fever”. Asia Pacific Journal of Public Health. SAGE Publications. doi:10.1177/101053950501700107.
- Abay, Tomas Ysehak, and Panayiotis A. Kyriacou. 2015. “Reflectance Photoplethysmography as Noninvasive Monitoring of Tissue Blood Perfusion”. IEEE Transactions on Biomedical Engineering. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tbme.2015.2417863.
- Sakudo A. Near-infrared spectroscopy for medical applications: Current status and future perspectives. Clin Chim Acta. 2016 Apr 1;455:181-8. doi: 10.1016/j.cca.2016.02.009. Epub 2016 Feb 12.
- Chiu WT, Lin PW, Chiou HY, Lee WS, Lee CN, Yang YY, Lee HM, Hsieh MS, Hu CJ, Ho YS, Deng WP, Hsu CY. Infrared thermography to mass-screen suspected SARS patients with fever. Asia Pac J Public Health. 2005;17(1):26-8. doi: 10.1177/101053950501700107.
- 2022. "A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05035420.
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Conditions
Cancer Related
Treatments