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

NCT04873193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-26

No results posted yet for this 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.

Conditions

  • Asthma in Children

Interventions

DEVICE

Leo device

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

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Andrew Liu · Children's Hospital Colorado

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-01-21
Completion
2022-01-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04873193 on ClinicalTrials.gov