A Pilot Study using Non-Contact Smartphone Cough Sound Recordings to Screenfor Chronic Obstructive Pulmonary Disease in an Indigenous Australian AdultPopulatio

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12620000144910
• Lead Sponsor: ResApp Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-12
• Last Update Posted: 16 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Must be able to provide written consent. Adults aged 22 years or older, coughing spontaneously or able to cough voluntarily, attending the study site:
1. without known acute or chronic respiratory disease
(i) with normal spirometry (termed healthy patients) or
(ii) with spirometry indicating COPD (termed COPD patients with no previous diagnosis)
a. subject must have had a spirometric assessment completed as a result of standard clinical care or be willing to undergo a spirometric assessment OR
2. with a historical diagnosis of COPD and history of smoking or other environmental exposure, or respiratory symptoms consistent with COPD.
a. subject must have had a spirometric assessment completed as a result of standard clinical care or be willing to undergo a spirometric assessment

Recruitment will occur at GRAMS - Geraldton Regional Aboriginal Medical Service, and as such will include an indigenous population.

Exclusion Criteria

1. Lack of consent
2. Patients with asthma and asthma-COPD comorbidity
3. Unable to provide at least 5 coughs sounds recognized by the study device
4. Medical contraindication to voluntary cough, including:
o Severe respiratory distress
o History of pneumothorax
o Eye, chest, or abdominal surgery within the past 3 months
5. Subjects with a clinical diagnosis of Tuberculosis, heart failure, lobectomy, neuromuscular disease or terminal disease
6. Structural airway disease including laryngo/tracheomalacia
7. Mechanical ventilation (invasive, CPAP, or BiPAP) or highflow nasal cannula
8. Too medically unstable to participate in study as per treating clinician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite primary outcome of positive percent agreement (PPA) and negative percent agreement (NPA) of the COPDCheck algorithms to diagnose and rule out chronic obstructive pulmonary disease (COPD).<br><br>Further detail on primary outcome:<br>The data will be evaluated by PPA, NPA, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-). The data will be evaluated by comparing the performance to previous studies and literature. [End of Study (when all participant data has been collected).]

Secondary Outcome Measures

Name	Time	Method
il[Nil]