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Evaluation of the AudibleHealth DxPro AI/ML-Based CDSS Using FCV-SDS in Screening for Tuberculosis

Evaluation of the Artificial Intelligence/Machine Learning-based Clinical Decision Support Software Using Forced Cough Vocalization Signal Data Signatures in Screening for Tuberculosis - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075990
Enrollment
200
Registered
2024-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A15- Respiratory tuberculosis

Interventions

Intervention1: AudibleHealth DxPro Clinical Decision Support Software (CDSS): The AudibleHealth DxPro is a clinical decision support software (CDSS) consisting of an ensemble of software subroutines t

Sponsors

Dr RPGMC Tanda Kangra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ·5 years of age and older ·Patients suggestive of pulmonary tuberculosis ·Stated willingness to comply with all trial procedures and availability for the duration of the trial ·Informed consent must be obtained before testing; completed by the subject, parent or guardian, or an emancipated minor ·Successful cough submission after applying any necessary filters on the SaMD

Exclusion criteria

Exclusion criteria: ·Under 5 years of age ·Unable to produce a voluntary forced cough vocalization (FCV) ·Recent (within the last year) acute traumatic injury to the head, neck, throat, chest, abdomen, or trunk ·Patent tracheostomy stoma ·Recent (within the last year) chest/abdomen/trunk trauma or surgery, recent/persistent neurovascular injury or recent intracranial surgery ·Medical history of cribriform plate injury or cribriform plate surgery, diaphragmatic hernia, external beam neck/throat / maxillofacial radiation, phrenic nerve injury/palsy, radical neck/throat/maxillofacial surgery, vocal cord trauma or nodules ·Since persons with aphasia may have difficulty in producing an FCV-SDS in the time allotted by the app, this population also will be excluded from the current trial.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of the intervention being used.Timepoint: The outcomes will be assessed at the baseline and thereafter every month till six months.

Secondary

MeasureTime frame
To ensure that the device is user friendly in accordance with REASSURED criteria from WHOTimepoint: At end of data collection

Countries

India

Contacts

Public ContactDr Sunil Raina

Dr RPGMC Tanda Kangra

ojasrainasunil@yahoo.co.in9418061066

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026