Leo Study Unstable Asthma

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05308277
• Other study ID #: RC-21-07-01
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: April 2023

Study information

• Verified date: September 2022
• Source: ResMed
• Contact: Faizan Javed, PhD
• Phone: +61 413624856
• Email: faizan.javed[@]resmed.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency and severity of localized skin reaction including redness and irritation / itchiness / discomfort.		7 days post hospital/ED discharge
Primary	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
Primary	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
Primary	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	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
Secondary	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