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A Prospective, Multicenter, Portable Pulmonary Function Comparison Study Aimed at Evaluating the External Clinical Validation of the Chronic Obstructive Pulmonary Disease Auxiliary Diagnostic Software LH-002 (Version: 2.0.0) in Clinical Diagnosis Accuracy
Sponsor: Ruijin Hospital
Summary
Chronic Obstructive Pulmonary Disease (COPD) is widely underdiagnosed in low- and middle-income countries and regions, due to the lack of accessible tools. Conventional spiromery tests for COPD diagnosis are expensive, require trained personnel to operate properly. Portable spirometry highly relies on the quality assurance of the tests. Since artificial intelligence (AI)-based cough analysis has demonstrated promising results in COPD diagnosis, this study aimed to evaluate the accuracy of an AI-based cough analysis software (Cough Search) compared to a portable spirometer for the auxiliary diagnosis of COPD.
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
OBSERVATIONAL
Enrollment
466
Start Date
2025-03-01
Completion Date
2026-06-30
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Locations (1)
Ruijin Hospital
Shanghai, China