Using cough sounds to identify tuberculosis
Automated Smartphone-based Cough Audio Classification for Rapid Tuberculosis Triage Testing (Cough Audio triaGE for TB; CAGE-TB)
This study is testing a smartphone app that listens to cough sounds to see if it can help identify tuberculosis in people who have been coughing for more than two weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1751 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | University of Stellenbosch Academic / other |
| Locations | 2 sites (Cape Town, Western Cape and 1 other locations) |
| Trial ID | NCT05317247 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the potential of a smartphone application that analyzes cough audio to triage patients for tuberculosis (TB) detection. Participants aged 12 and older with a cough lasting more than two weeks will be recruited from healthcare clinics in high-burden settings. The study consists of two phases: the first phase collects data to train a machine learning algorithm, while the second phase validates the algorithm's performance with a larger participant group. The goal is to develop a reliable cough audio classifier that meets World Health Organization criteria for TB triage tests.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 and older who have a cough lasting more than two weeks and are willing to provide informed consent.
Not a fit: Patients who have received TB treatment in the past 60 days or those unable to provide a sputum specimen will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the speed and accuracy of TB diagnosis, leading to timely treatment and better patient outcomes.
How similar studies have performed: While the use of cough audio classification for TB detection is a novel approach, similar technologies in other areas of diagnostics have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * participant must be at least 12 years old * participant must have a prolonged cough (for at least two weeks) * participant must provide informed consent * participant shall have a known HIV status or be willing to undergo standard of care HIV testing and counseling Exclusion Criteria: * individuals who refuse informed consent * individuals who have received treatment for TB in the 60 days prior to enrolment * individuals who are unable to provide a sputum specimen for microbiological testing * individuals who have haemoptysis or a bloody cough with any forced coughs for audio recordings
Where this trial is running
Cape Town, Western Cape and 1 other locations
- Stellenbosch University — Cape Town, Western Cape, South Africa (Recruiting)
- Makerere University — Kampala, Kampala, Uganda (Recruiting)
Study contacts
- Principal investigator: Grant Theron, PhD — University of Stellenbosch
- Study coordinator: Grant Theron, PhD
- Email: gtheron@sun.ac.za
- Phone: +27 21 9389693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.