Clinical trial NCT04873193: Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children
Official title: Safety and Feasibility of Utilizing a Novel Wearable Device (Leo) for Assessing Respiratory Function in Children With Respiratory Condition - a Pilot Early Phase Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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, 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Slow vital capacity from Leo device
timeFrame: Baseline
measure: Slow vital capacity from PNT device
timeFrame: Baseline
measure: Tidal breathing from Leo device
timeFrame: Baseline
measure: Tidal breathing from PNT device
timeFrame: Baseline
Secondary outcomes:
measure: Usability
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Colorado Hospital
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Andrew Liu
role: PRINCIPAL_INVESTIGATOR
References: