Evaluation of the Artificial Intelligence/Machine Learning-based Clinical Decision Support Software Using Forced Cough Vocalization Signal Data Signatures in Screening for Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the intervention being used.
研究概览
简要总结
Participants with symptoms suggestive of pulmonary tuberculosis will be enrolled. The evaluation tests as per the standard protocols will be performed to confirm the diagnosis of pulmonary TB in this identified cohort. In addition, an AudibleHealth DxPro test will be performed on all these patients. Subjects and staff will be blinded to AudibleHealth DxPro results. No one will know both results in real-time except for the Site Coordinators specifically authorized to have these results for enrollment, audit, data tracking, and data compiling purposes. Unblinding of the results will occur after the AudibleHealth DxPro and the routine diagnostic test results have been obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Â·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.
排除标准
- •Â·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.
结局指标
主要结局
Sensitivity and specificity of the intervention being used.
时间窗: The outcomes will be assessed at the baseline and thereafter every month till six months.
次要结局
- To ensure that the device is user friendly in accordance with REASSURED criteria from WHO(At end of data collection)
研究者
Dr Sunil Raina
Dr RPGMC Tanda Kangra