Leo Study Unstable Asthma

Engineering Validation of Leo Device to Assess Clinical Control of Children Recovering From Acute Asthma Exacerbation

This is a prospective, observational study to investigate the agreement of the Leo device signal derivation with gold standard asthmatic testing in recently exacerbated asthmatic children.

This study is designed for engineering validation of a wireless, wearable device (Leo) for assessing clinical control of children recovering from acute respiratory event such as asthma attack. The Leo device will monitor chest impedance, ECG and body position to calculate parameters such as respiration rate, heart rate, lung volume, tidal breathing flow and volume curves, and body position. These parameters will then be used to train and algorithm to assess clinical control of asthma.

Study Overview

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

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

Contacts and Locations

• Study Contact: Name: Faizan Javed, PhD; Phone Number: +61 413624856; Email: faizan.javed@resmed.com.au

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Juana Cerna, MS; Phone Number: 720-777-8384

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children aged ≥2 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
• Children who are currently hospitalized with acute exacerbation of asthma
• Child's caregiver is able to communicate using SMS
• Child has an asthma inhaler

Exclusion Criteria:

• Children with complex medical conditions which may hinder their ability to complete protocol assessments
• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Single Arm - Leo Device Monitoring; Child's respiratory impedance will be continuously recorded using the Leo device during hospital/ED stay after consent and enrollment, and then during 7 days at home after discharge. The Leo device provides no intervention, and will only monitoring chest impedance for the worn period. Oscillometry and spirometry testing and flow volume assessment using PNT will be performed during study visits with Leo device attached.

Device: Leo device monitoring; After consent and enrollment, the child's respiratory impedance will be continuously recorded using the Leo device throughout the day and night during the entire hospital stay or ED visit. The device may be taken off for up to 1 hour per day (i.e., break during bath / shower time). The device will be applied to the skin overlying the mid-sternum area on the chest wall after cleaning of the skin with an alcohol swab after consent has been obtained. The device will be changed every 72 hours or earlier, by the participant's guardian, depending on signs of defect in the signal quality or battery exhaustion, based on daily check of the signal by the research team. Remote monitoring of the child's chest impedance will continue using the Leo device after discharge from hospital/ED for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway resistance through oscillometry test	Asthma severity measures will be determined through oscillometry test at baseline and follow-up visit. Leo measurements will be assessed for agreement with oscillometry measures.	Baseline visit and 7 days post hospital/ED discharge
Asthma Flare-up diary	Self-reported asthma flare-up diary score will be measured daily during the remote (at home) period in between visits.	Follow-up for 7 days post hospital/ED discharge
CASI questionnaire	Questionnaire will be used to determine asthma severity during baseline and follow-up visit. CASI scores include five domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. Range is from 0 -17, with a higher score indicating worse asthma severity	Baseline visit and 7 days post hospital/ED discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhaler usage	Propeller sensor will include measures of time stamped data of inhaler usage (controller and rescue inhalers)	Follow-up for 7 days post hospital/ED discharge
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 agreement.	7 days post hospital/ED discharge

Other Outcome Measures

Outcome Measure	Time Frame
Frequency and severity of localized skin reaction including redness and irritation / itchiness / discomfort.	7 days post hospital/ED discharge

Collaborators and Investigators

• Sponsor: ResMed

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 4, 2022

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: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: RC-21-07-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared through planned publications after de-identified analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; 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