Leo Study Unstable Asthma

Not Applicable

Recruiting

• Conditions: Asthma in Children

• Registration Number: NCT05308277
• Lead Sponsor: ResMed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-04-04
• Study Start: 2022-04-27
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Airway resistance through oscillometry test	Baseline visit and 7 days post hospital/ED discharge	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.
CASI questionnaire	Baseline visit and 7 days post hospital/ED discharge	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
Asthma Flare-up diary	Follow-up for 7 days post hospital/ED discharge	Self-reported asthma flare-up diary score will be measured daily during the remote (at home) period in between visits.

Secondary Outcome Measures

Name	Time	Method
Inhaler usage	Follow-up for 7 days post hospital/ED discharge	Propeller sensor will include measures of time stamped data of inhaler usage (controller and rescue inhalers)
Tidal breathing from PNT device	7 days post hospital/ED discharge	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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States