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

ResMed

Status: Completed

Conditions: Asthma in Children

Treatments: Device: Leo device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04873193

OTH-21-02-01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Oscillometry + Pneumotach Procedure with Leo Device measurements

Other group

Description:

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.

Treatment:

Device: Leo device