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)

Not Applicable

Completed

• Conditions: asthma; Respiratory - Asthma

• Registration Number: ACTRN12621000182897
• Lead Sponsor: ResMed Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-22
• Study Completion: 2022-10-28
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified