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Trial registered on ANZCTR


Registration number
ACTRN12621001086853
Ethics application status
Approved
Date submitted
5/07/2021
Date registered
17/08/2021
Date last updated
22/07/2022
Date data sharing statement initially provided
17/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Breathe Easy study: Mask On, Mask Off (MoMo) sub study for diagnosis of respiratory illness
Scientific title
Diagnosis of respiratory illness using non-contact sound recordings. A Breathe Easy Study Sub-Study: Mask-on Mask-off (MoMo)
Secondary ID [1] 304698 0
None
Universal Trial Number (UTN)
U1111-1267-6294
Trial acronym
MoMo (Mask on, Mask off)
Linked study record
This record is a sub-study of ACTRN12618001521213

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 322704 0
Asthma 322705 0
Chronic Obstructive Pulmonary Disease (COPD) 322706 0
Lower respiratory tract disease 322707 0
Condition category
Condition code
Respiratory 320298 320298 0 0
Asthma
Respiratory 320299 320299 0 0
Chronic obstructive pulmonary disease
Respiratory 320300 320300 0 0
Other respiratory disorders / diseases
Infection 320535 320535 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients over 12 years of age with defined respiratory conditions (including Asthma, COPD, Pneumonia, Upper and Lower Respiratory infections), confirmed by expert review, will provide two series of (5) coughs, recorded on a smartphone: one series with a standard surgical mask on and one without a mask, for analysis. This procedure takes 30 seconds when the patient can provide a voluntary cough and up to 5 minutes if spontaneous. The procedure will be undertaken by a trained research nurse on one occasion only. The recordings will be analysed by an algorithm, housed on the smartphone that gives a point of care diagnosis. The application delivers a dichotomous result (“DISEASE PRESENT” or “DISEASE ABSENT” in a coded form).

Both the App and clinical diagnostic results are blinded and are derived independently of each other.

Clinical diagnosis and algorithm diagnosis (coded output) will be provided separately to an independent statistician for analysis. The specialist treating team will independently arrive at all clinical diagnoses (without knowing the App output/diagnosis).

Data is collected in during one encounter, without "wash out". Participants will provide 5 coughs without a mask followed by 5 coughs with a surgical mask on in that order.

Study Blinding
Clinical diagnoses will be determined by the clinical team and completed prior to index test analysis.

The application delivers a dichotomous result (“DISEASE PRESENT” or “DISEASE ABSENT” in a coded form.

Both results are blinded to each other and are conducted independently of each other.


The algorithm output will be compared to the non-standard reference clinical diagnosis by an independent statistical team.
Intervention code [1] 321079 0
Diagnosis / Prognosis
Comparator / control treatment

A specialist respiratory physician and a specialist paediatrician will determine the clinical diagnosis of all patients using standard diagnostic protocols and definitions as the study comparator. The diagnosis will be arrived at using all available clinical data including history, examination, radiology, laboratory and lung function test results.

The algorithm output will be compared to the non-standard reference clinical diagnosis by an independent statistical team.
Control group
Active

Outcomes
Primary outcome [1] 328154 0
The primary outcome is the measures of agreement between the algorithm result obtained with a mask to clinical diagnosis.. As a clinical diagnosis is a non-reference standard, Postive and negative percent agreement will be determined rather than sensitivity and specificity.
Timepoint [1] 328154 0
Codes will be generated immediately but only unblinded at the end of the study
Secondary outcome [1] 397868 0
A secondary outcome is the measures of agreement between the algorithm result obtained without a mask to clinical diagnosis.. As a clinical diagnosis is a non-reference standard, Postive and negative percent agreement will be determined rather than sensitivity and specificity.
Timepoint [1] 397868 0
Codes will be generated immediately but only unblinded at the end of the study
Secondary outcome [2] 398704 0
A secondary outcome is the measures of agreement between the algorithm result obtained with a mask to the algorithm result without a mask.. Sensitivity and specificity will be the measures used to analyse the data.
Timepoint [2] 398704 0
Codes will be generated immediately but only unblinded at the end of the study.

Eligibility
Key inclusion criteria
Any adolescent or adult over 12 years of age presenting to low acuity ambulatory care units, respiratory medicine clinics, the ED or admitted to the ward of a participating institution with a diagnosis of asthma, COPD, pneumonia, or lower respiratory disease.

Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of a signed consent form
Need for ventilatory support (including non-invasive means such as CPAP, high flow nasal oxygen, BiPAP),
Terminal disease.
Medical contraindication to voluntary cough, including severe respiratory distress, history of pneumothorax, eye, chest or abdominal surgery within the past 3 months
Too medically unstable to participate in study as per attending clinician.
Structural airway disease including laryngomalacia or tracheomalacia.
Acute Heart failure
Neuromuscular disease
Lobectomy

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Each participant will provide 5 coughs with the mask off followed by 5 coughs with the mask on. This sequence will be constant throughout the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Measures of agreement of:

1. Algorithm (coded result with mask) vs algorithm (coded result without mask)
2. Algorithm (coded result with mask) vs routine clinical diagnosis
3. Algorithm (coded result without mask) vs routine clinical diagnosis

As a non-reference standard test is used as the comparator, the primary measures of diagnostic agreement used will be Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). PPA are those clinical diagnosis-positive cases who are also positive for the index test; NPA are those clinical diagnosis-negative cases who are also negative for the index test. 95% confidence intervals around these parameters will be calculated using the method of Clopper-Pearson.

Based on expected PPA and NPA results greater than 85% from previous work, to obtain a superiority end-point of 75% (lower bound 95% CI of maximum width ±0.10) a minimum of 48 cases is required for each disease. Assuming a 10% attrition rate, a minimum cohort of 200 is needed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/08/2021
Actual
13/08/2021
Date of last participant enrolment
Anticipated
1/08/2022
Actual
31/01/2022
Date of last data collection
Anticipated
1/08/2022
Actual
30/06/2022
Sample size
Target
200
Accrual to date
Final
221
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 19916 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 34617 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 309066 0
Commercial sector/Industry
Name [1] 309066 0
ResApp Health
Country [1] 309066 0
Australia
Primary sponsor type
Individual
Name
Paul Porter
Address
Suite 204, Medical Centre, Joondalup Health Campus, Grand Boulevarde, Joondalup. Western Australia, 6027
Country
Australia
Secondary sponsor category [1] 310013 0
None
Name [1] 310013 0
Address [1] 310013 0
Country [1] 310013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308943 0
Ramsay Healthcare HREC, Western and South Australia
Ethics committee address [1] 308943 0
Ethics committee country [1] 308943 0
Australia
Date submitted for ethics approval [1] 308943 0
16/11/2020
Approval date [1] 308943 0
12/01/2021
Ethics approval number [1] 308943 0
1501

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112414 0
A/Prof Paul Porter
Address 112414 0
Joondalup Health Campus, Grand Boulevarde, Joondalup, Western Australia, 6027
Country 112414 0
Australia
Phone 112414 0
+61412484747
Fax 112414 0
+610894009909
Email 112414 0
[email protected]
Contact person for public queries
Name 112415 0
Paul Porter
Address 112415 0
Joondalup Health Campus, Grand Boulevarde, Joondalup, Western Australia, 6027
Country 112415 0
Australia
Phone 112415 0
+61412484747
Fax 112415 0
+610894009909
Email 112415 0
[email protected]
Contact person for scientific queries
Name 112416 0
Paul Porter
Address 112416 0
Joondalup Health Campus, Grand Boulevarde, Joondalup, Western Australia, 6027
Country 112416 0
Australia
Phone 112416 0
+61412484747
Fax 112416 0
+610894009909
Email 112416 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who have obtained approprite ethical approval.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Deidentified data for calculation of measures of agreement.

What types of analyses could be done with individual participant data?
• Recalculation of results

When can requests for individual participant data be made (start and end dates)?
From:
From August 2022 (end of trial) until 5 years after publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• On request to PI ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12425Study protocol    Study-related document.docx
12427Ethical approval    Study-related document.pdf



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.