NCT04873193

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma in Children

Interventions

Type	Name	Description
DEVICE	Leo device	Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-01-21
• Completion: 2022-01-21
• First posted: 2021-05-05
• Last updated: 2022-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study