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NCT04003415 · ClinicalTrials.gov registry record · NA
Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients
A NA study of Asthma and COPD, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04003415: Completed NA study of Asthma and COPD, sponsored by Stanford University.
NCT04003415 is a NA study of Asthma and COPD that has completed, run by Stanford University. The registered enrollment target is 12 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04003415, a NA study of Asthma and COPD, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the accuracy of an investigational, non-invasive device for measuring heart rate and respiratory rate. The device emits radiowaves that allows it to pick up subtle changes in a person's chest wall, which allows it to calculate the heart rate and respiratory rate. We propose to study whether the device's measurements are accurate and reproducible in patients with chronic obstructive pulmonary disease (COPD) or asthma. The device undergoing study has been evaluated in healthy volunteers, but its accuracy in vital sign monitoring in patients with respiratory conditions has not yet been established. This study will serve as the foundation for additional work to assess the device's accuracy in measuring a patient's overall "work of breathing" or respiratory effort. Future work will examine the device's accuracy in measuring work of breathing in patients having an exacerbation of their underlying respiratory condition. The primary aim of this study will be to assess the validity of heart rate and respiratory rate measurements in patients with either COPD or asthma.
Primary Outcome
Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.
Conditions Studied
Interventions
- DEVICE Investigational Device: Contactless heart rate and respiratory rate monitor
- DIAGNOSTIC_TEST Heart Rate (EKG) Monitor
- DIAGNOSTIC_TEST Respiratory rate Monitor
- DIAGNOSTIC_TEST Pulse Oximetry
Study Locations (1)
California
- Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-03-01 |
| Est. Completion | 2021-09-20 |
| Phase | NA |
What the finished NCT04003415 record still lists
NCT04003415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which Investigational Device: Contactless heart rate and respiratory rate monitor is the first listed.
NCT04003415 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04003415 about?
NCT04003415 is a clinical study titled "Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients". This study will test the accuracy of an investigational, non-invasive device for measuring heart rate and respiratory rate. The device emits radiowaves that allows it to pick up subtle changes in a person's chest wall, which allows it to calculate the heart rate and respiratory rate. We propose to s...
What is the current status of trial NCT04003415?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2020-03-01. Estimated completion is 2021-09-20.
What conditions does trial NCT04003415 study?
This clinical trial studies the following conditions: Asthma, COPD, Respiratory Effort, Contactless Vital Sign Monitoring.
What interventions are being tested in trial NCT04003415?
The interventions under investigation include: Investigational Device: Contactless heart rate and respiratory rate monitor (DEVICE), Heart Rate (EKG) Monitor (DIAGNOSTIC_TEST), Respiratory rate Monitor (DIAGNOSTIC_TEST), Pulse Oximetry (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04003415?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04003415 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04003415's enrollment target sits among peer trials
12 360th of 374 higher than 9 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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