跳至主要内容
临床试验/CTRI/2025/03/081842
CTRI/2025/03/081842尚未招募不适用

Diagnostic accuracy of an AI based screening system for detection of pulmonary tuberculosis using cough sounds and symptoms

AIIMS Delhi /Lords Education & Health Society1 个研究点 分布在 1 个国家目标入组 1,260 人开始时间: 2025年3月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,260
试验地点
1
主要终点
To evaluate the sensitivity, specificity, and accuracy of the AI solution in the detection of patients with TB, using cough sounds, comorbidity and symptom history

研究概览

简要总结

This study aims to evaluate the diagnostic accuracy of an artificial intelligence (AI)-based screening system designed for the detection of pulmonary tuberculosis (TB) using cough sounds and related symptoms. TB remains a significant global health challenge, with 10.6 million new cases and 1.3 million deaths annually. Traditional diagnostic methods like microbiological tests and chest X-rays, though effective, are resource-intensive and often inaccessible in low-resource settings. This has led to significant gaps in the detection and treatment of TB, particularly in rural areas. The AI model developed in this study uses cough sounds—a prominent symptom of TB—and additional symptoms such as fever, weight loss, and night sweats to provide a cost-effective and non-invasive diagnostic tool. The AI-powered mobile application offers rapid, point-of-care screening and can be utilized by frontline healthcare workers, enabling early diagnosis even in resource-limited environments. This technology addresses the need for accessible TB screening, aiming to bridge the gap between diagnosed and undiagnosed cases.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age greater than 18 years Cough of any duration Willing to give consent.

排除标准

  • Individuals less than 18 years of age Patients unwilling to give consent Patients requiring emergency management (clinically unstable) Pregnant women, patients with pacemakers etc.
  • among whom X-ray is prohibited Patients currently on antitubercular therapy.

结局指标

主要结局

To evaluate the sensitivity, specificity, and accuracy of the AI solution in the detection of patients with TB, using cough sounds, comorbidity and symptom history

时间窗: at 6 months and at 12 months (or till 126 confirmed TB positive patients are found; whichever is earlier)

次要结局

未报告次要终点

研究者

发起方
AIIMS Delhi /Lords Education & Health Society
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Neeraj Nischal

Dept. of Medicine, AIIMS, New Delhi

研究点 (1)

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