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This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as asthma).
There is no product currently on the market that is comparable to this novel Leo device
The study consists of a single visit to evaluate the feasibility and safety of using the Leo device on 20 children with clinically stable asthma.
Stable asthmatic children between the age of 3 and 6, inclusive, will be recruited.
There will be no disease-specific intervention, nor changes to the participant's care management program for their asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oscillometry + Pneumotach Procedure with Leo Device measurements | Other | All patients will undergo oscillometry procedure, followed by pneumotach procedure to measure tidal volume in different sitting positions. The Leo device will be worn throughout both procedures to measure the chest electrical impedance and compare against pneumotach measurements. Oscillometry and pneumotach are part of standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leo device | Device | Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Slow vital capacity from Leo device | Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device. The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator. | Baseline |
| Slow vital capacity from PNT device | Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device. The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility. This will be done before and after administration of bronchodilator. | Baseline |
| Tidal breathing from Leo 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 for device feasibility. This will be done before and after administration of bronchodilator. | Baseline |
| 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 for device feasibility. This will be done before and after administration of bronchodilator. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Clinician, patient and caregiver usability feedback on the use of the Leo device through an IRB approved participant questionnaire. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Liu | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Colorado Hospital | Aurora | Colorado | 80045 | United States |
De-identified data only
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