Leo Study Unstable Asthma

NAUnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 27, 2022

Primary Completion Date

April 30, 2023

Study Completion Date

April 30, 2023

Conditions
Asthma in Children
Interventions
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.

Trial Locations (1)

80045

RECRUITING

Children's Hospital Colorado, Aurora

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ResMed

INDUSTRY

NCT05308277 - Leo Study Unstable Asthma | Biotech Hunter | Biotech Hunter