Safety and feasibility of utilising a novel wearable device (Leo) for assessing respiratory function in children with and without respiratory condition - a pilot early phase clinical study (Phase 1)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000182897

Enrollment

Registered

2021-02-22

Start date

2021-03-15

Completion date

2022-10-28

Last updated

2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 and without respiratory conditions (such as asthma) There is no product on the market currently that is comparable to this novel Leo device This study is a single visit to evaluate the correlation between breathing signals collected by the Leo device with those collected through lung function tests. 40 children will be included. 20 children with clinically stable asthma and 20 healthy children There will be no disease-specific intervention, nor changes to the participant’s care management program for their asthma

Interventions

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 and without respiratory condition (such as asthma). The Leo device is attached to the upper part of the chest using a medical grade replaceable adhesive. The device will be attached to the childs chest by the study nurse. The child will wear the device for approximately 30 minutes while undergoing lung function tests and quiet breathing (measured by a pneumotachometer)

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Eligibility

Sex/Gender

All

Age

5 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

Children aged at least 5 years old and less than 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 PI confirmation for diagnosis into each of the study cohorts: A) Healthy children without respiratory condition (no documented history of respiratory disease), history or preterm birth (less than 37 weeks gestation), primary immunodeficiency, neuromuscular disease, chronic heart condition B) Clinically stable respiratory condition, such as clinically diagnosed asthma Children who are able to follow instructions and complete spirometry test

Exclusion criteria

- Children less than 5 years of age - Adults (age 18 years or over) - 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 - No additional respiratory symptoms, including cough or fever, within the 4 weeks prior to enrolment - 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

Outcome results