Leo Study Unstable Asthma
- Conditions
- Asthma in Children
- Interventions
- Device: Leo device monitoring
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
- Arm && Interventions
Group Intervention Description Single Arm - Leo Device Monitoring 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.
- Primary Outcome Measures
Name Time Method 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.
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.
- 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