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Stratifying asthma severity in children using cough sound analytic technology.

Stratifying asthma severity in children using cough sound analytic technology. A sub-study of the Breathe Easy Study: Developing digital diagnostic tests for respiratory diseases using non-contact sound recordings in children and adults.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001832268
Enrollment
224
Registered
2018-11-09
Start date
2015-03-23
Completion date
2016-12-01
Last updated
2022-08-09

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 study is designed to develop an accurate digital diagnostic test, used on a smart device, to measure the severity of asthma. These tests can then be used in resource-poor communities, emergency departments or via telehealth applications. The test would improve asthma action plans, a mainstay of asthma management. The aim is to develop tests that are as accurate as an expert clinical assessment but do not need a clinical examination or other interventions such as bronchodilator (Ventolin) tests.

Interventions

We use the collected data and cough recordings obtained in the Breathe Easy Study (ACTRN12618001521213). This dataset consists of a training set with coupled cough recordings, clinical data and single adjudicator diagnostic evaluation and a testing set with cough recordings, clinical data and a consensus panel adjudicator diagnostic evaluation. Phase 1 of the trial is to use the training set to develop the mathematical models to predict asthma severity using well known commonly used clinical

We use the collected data and cough recordings obtained in the Breathe Easy Study (ACTRN12618001521213). This dataset consists of a training set with coupled cough recordings, clinical data and single adjudicator diagnostic evaluation and a testing set with cough recordings, clinical data and a consensus panel adjudicator diagnostic evaluation. Phase 1 of the trial is to use the training set to develop the mathematical models to predict asthma severity using well known commonly used clinical scales (eg Pulmonary Score). Phase 2 of the trial is to use the testing set to perform a diagnostic accuracy study. The Breathe Easy protocol requires patients with defined respiratory conditions (including Asthma, COPD, Bronchiolitis, Croup, Interstitial Lung Disease, Pneumonia, Upper and Lower Respiratory infections, Bronchiectasis, Emphysema), confirmed by expert review, to provide one series of (5-10) coughs, recorded by a smartphone for analysis and technical development of an algorithm to produce a digital diagnostic test. This procedure takes 30 seconds when the patient can provide a voluntary cough and up to 5 minutes if spontaneous. Children (who are able to cough on demand or are doing so spontaneously) and adults will be approached by a trained research nurse. The recordings are collected at two Perth hospitals in the emergency department, inpatient wards and ambulatory care settings.

Sponsors

Paul Porter
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
10 Months to No maximum
Healthy volunteers
No

Inclusion criteria

Clinical diagnosis of asthma. As a substudy of the Breathe Easy study, the cohort has already been screened for the criteria below. 1. Patients with a history of a chronic respiratory condition or who have symptoms of an acute respiratory disease. 2. Patients without acute respiratory disease, with and without a history of asthma.

Exclusion criteria

As a substudy of the Breathe Easy study, the cohort has already been screened for the criteria below. Inability to Provide a cough either spontaneously or voluntarily. Unable to provide informed consent or assent Severe respiratory distress including the use of CPAP or BiPAP Abdominal or eye surgery within 3 months

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026