Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children

Inclusion criteria

• 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 criteria

• - 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.