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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: Completed NA study, sponsored by ResMed.
NCT04873193 is a NA study that has completed, run by ResMed. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device. The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.
Interventions
- DEVICE Leo device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2022-01-21 |
| Phase | NA |
What the finished NCT04873193 record still lists
NCT04873193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Leo device is the first listed.
NCT04873193 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04873193's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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