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NCT04873193 · ClinicalTrials.gov registry record · NA
Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children
A NA study, sponsored by ResMed.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT04873193 is a NA study that has completed, run by ResMed. The registered enrollment target is 30 participants.
The verdict
NCT04873193, a NA study, has completed, sponsored by ResMed.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as asthma). There is no product currently on the market that is comparable to this novel Leo device The study consists of a single visit to evaluate the feasibility and safety of using the Leo device on 20 children with clinically stable asthma. Stable asthmatic children between the age of 3 and 6, inclusive, will be recruited. There will be no disease-specific intervention, nor changes to the participant's care management program for their asthma.
Interventions
- DEVICE Leo device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2022-01-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04873193
The ClinicalTrials.gov registry entry for NCT04873193 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ResMed, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Leo device is the first listed.
NCT04873193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04873193 about?
NCT04873193 is a clinical study titled "Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children". This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condi...
What is the current status of trial NCT04873193?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2021-07-01. Estimated completion is 2022-01-21.
What interventions are being tested in trial NCT04873193?
The interventions under investigation include: Leo device (DEVICE).
Who is sponsoring clinical trial NCT04873193?
This trial is sponsored by ResMed, which has 25 total clinical trials registered on ClinicalTrials.gov.
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