Status:
UNKNOWN
Leo Study Unstable Asthma
Lead Sponsor:
ResMed
Conditions:
Asthma in Children
Eligibility:
All Genders
2-18 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05308277
Start Date
April 27 2022
End Date
April 1 2023
Last Update
September 26 2022
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045