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NCT05035420 · ClinicalTrials.gov registry record · NA
A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases
A NA study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05035420 is a NA study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 40 participants.
The verdict
NCT05035420, a NA study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Background: 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.
Interventions
- DEVICE Fitbit
- DEVICE Douglas Bag
- DEVICE Periflux 6000 EPOS
- DEVICE BIOPAC
- DEVICE Flowmet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-05-26 |
| Est. Completion | 2025-08-27 |
| Phase | NA |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05035420
The ClinicalTrials.gov registry entry for NCT05035420 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fitbit is the first listed.
NCT05035420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05035420 about?
NCT05035420 is a clinical study titled "A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases". Background: 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. Objecti...
What is the current status of trial NCT05035420?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2022-05-26. Estimated completion is 2025-08-27.
What interventions are being tested in trial NCT05035420?
The interventions under investigation include: Fitbit (DEVICE), Douglas Bag (DEVICE), Periflux 6000 EPOS (DEVICE), BIOPAC (DEVICE), Flowmet (DEVICE).
Who is sponsoring clinical trial NCT05035420?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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