Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000182897
Ethics application status
Approved
Date submitted
9/12/2020
Date registered
22/02/2021
Date last updated
6/02/2023
Date data sharing statement initially provided
22/02/2021
Date results information initially provided
6/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
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)
Scientific title
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)
Secondary ID [1] 302991 0
OTH-20-10-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 320042 0
Condition category
Condition code
Respiratory 317968 317968 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 319277 0
Early detection / Screening
Intervention code [2] 319278 0
Diagnosis / Prognosis
Comparator / control treatment
While participants are wearing the Leo patch, they will be asked to breathe through a mouth piece connected to a pneumotachometer. This is considered the gold standard for measuring respiratory function. Participants will be asked to undergo lung function tests along with quiet breathing. The tasks will be administered by the study nurse and will take approximately 30-45 minutes. Data collected by the pneumotachometer will be compared with data collected by the Leo device
Control group
Active

Outcomes
Primary outcome [1] 325980 0
Agreement and correlation in FVC derived using the respiratory impedance signals recorded from Leo device and the pneumotachograph (PNT) device
Timepoint [1] 325980 0
Whilst the participant is wearing the LEO device, FVC will be collected over 3 attempts during a single visit and an average of the three attempts will be calculated.
Primary outcome [2] 326189 0
Agreement and correlation in Forced Expiratory Volume ( FEV1) derived using the respiratory impedance signals recorded from Leo device and the pneumotachograph (PNT) device
Timepoint [2] 326189 0
Whilst the participant is wearing the Leo device, 3 FEV1 attempts will be made during a single visit and an average of the 3 attempts will be calculated
Primary outcome [3] 326190 0
Agreement in correlation in quiet breathing between the signals recorded from the Leo device and the PNT device
Timepoint [3] 326190 0
5 minutes of quiet breathing will be collected during a single visit
Secondary outcome [1] 390696 0
Safety of the Leo patch. Safety refers to any incidence of red marks, rash or skin irritation on or around the site of the Leo patch. This information is recorded on a study specific questionnaire
Timepoint [1] 390696 0
The questionnaire is completed at the end of the Phase 1 study visit

Eligibility
Key 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
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2021
Actual
15/03/2021
Date of last participant enrolment
Anticipated
30/07/2022
Actual
28/10/2022
Date of last data collection
Anticipated
30/08/2022
Actual
28/10/2022
Sample size
Target
40
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307401 0
Commercial sector/Industry
Name [1] 307401 0
ResMed Ltd
Country [1] 307401 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResMed Ltd
Address
1 Elizabeth Macarthur Drive, Bella Vista, NSW, 2153
Country
Australia
Secondary sponsor category [1] 308063 0
None
Name [1] 308063 0
Address [1] 308063 0
Country [1] 308063 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307487 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 307487 0
Corner Hawkesbury Road
and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145
Sydney Australia
Ethics committee country [1] 307487 0
Australia
Date submitted for ethics approval [1] 307487 0
Approval date [1] 307487 0
04/12/2020
Ethics approval number [1] 307487 0

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107406 0
Dr Sandra Chuang
Address 107406 0
Respiratory Medicine Department
1 High St, Randwick NSW 2031
Sydney Children’s Hospital, Randwick
Country 107406 0
Australia
Phone 107406 0
+61293821475
Fax 107406 0
Email 107406 0
[email protected]
Contact person for public queries
Name 107407 0
Dr Sandra Chuang
Address 107407 0
Respiratory Medicine Department
1 High St, Randwick NSW 2031
Sydney Children’s Hospital, Randwick
Country 107407 0
Australia
Phone 107407 0
+61293821475
Fax 107407 0
Email 107407 0
[email protected]
Contact person for scientific queries
Name 107408 0
Dr Sandra Chuang
Address 107408 0
Respiratory Medicine Department
1 High St, Randwick NSW 2031
Sydney Children’s Hospital, Randwick
Country 107408 0
Australia
Phone 107408 0
+61293821475
Fax 107408 0
Email 107408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.