Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04873193
Status:
COMPLETED
Last Update Posted:
2022-09-26
First Post:
2021-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children
Sponsor:
ResMed
Organization:
Study Overview
Official Title:
Safety and Feasibility of Utilizing a Novel Wearable Device (Leo) for Assessing Respiratory Function in Children With Respiratory Condition - a Pilot Early Phase Clinical Study
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: