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Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children

Asthma in Children Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04873193
Study type Interventional
Source ResMed
Contact
Status Completed
Phase N/A
Start date July 1, 2021
Completion date January 21, 2022
View Details
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