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

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Device: Leo device

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children aged ≥3 years old and ≤18 years old at time of consent
• Children with a legal guardian able to sign consent for study participation
• Children and caregivers able to read and understand English or Spanish
• Investigator confirmation for diagnosis of clinically stable respiratory condition, such as clinically diagnosed asthma
• Children who are able to follow instructions and complete oscillometry and tidal breathing tasks

Exclusion Criteria:

• - Children <3 and >18 years of age
• Adults (age ≥ 18 years)
• Children with complex medical conditions which may hinder their ability to complete protocol assessments
• Children who do not have a legal guardian to sign informed consent form
• Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
• Child is determined not eligible by the assessment of the PI
• Fever within the 4 weeks prior to enrollment
• Children with any implanted medical devices, E.g. cardiac pacemaker
• Children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the Leo device
• Children who have taken a bronchodilator in the last 8-24 hours prior to study visit, depending on the type of medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Oscillometry + Pneumotach Procedure with Leo Device measurements; All patients will undergo oscillometry procedure, followed by pneumotach procedure to measure tidal volume in different sitting positions. The Leo device will be worn throughout both procedures to measure the chest electrical impedance and compare against pneumotach measurements. Oscillometry and pneumotach are part of standard of care.

Device: Leo device; Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures.; Other Names: Pneumotachometer (BioPaC systems, Inc., Goleta, CA, USA) connected to anti-bacterial filter and mouth piece.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slow vital capacity from Leo device	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.	Baseline
Slow vital capacity from PNT device	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.	Baseline
Tidal breathing from Leo device	Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device. The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.	Baseline
Tidal breathing from PNT device	Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device. The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Clinician, patient and caregiver usability feedback on the use of the Leo device through an IRB approved participant questionnaire.	Baseline

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Andrew Liu, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): January 21, 2022
• Study Completion (Actual): January 21, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: OTH-21-02-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified data only
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No