Status:
COMPLETED
Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children
Lead Sponsor:
ResMed
Conditions:
Asthma in Children
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief Summary
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, he...
Eligibility Criteria
Inclusion
- Children aged ≥3 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
- Investigator confirmation for diagnosis of clinically stable respiratory condition, such as clinically diagnosed asthma
- Children who are able to follow instructions and complete oscillometry and tidal breathing tasks
Exclusion
- \- Children \<3 and \>18 years of age
- Adults (age ≥ 18 years)
- Children with complex medical conditions which may hinder their ability to complete protocol assessments
- Children who do not have a legal guardian to sign informed consent form
- 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
- Child is determined not eligible by the assessment of the PI
- Fever within the 4 weeks prior to enrollment
- 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
- Children who have taken a bronchodilator in the last 8-24 hours prior to study visit, depending on the type of medication.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04873193
Start Date
July 1 2021
End Date
January 21 2022
Last Update
September 26 2022
Active Locations (1)
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1
Children's Colorado Hospital
Aurora, Colorado, United States, 80045