A Clinical Validation Study to Evaluate the Diagnostic Accuracy of a Cough-based Auxiliary Diagnosis Algorithm for COPD

Recruiting

• Conditions: COPD; Cough; Algorithm

• Registration Number: NCT06082791
• Lead Sponsor: Ruijin Hospital

Brief Summary

Cough is one of the most common symptoms in COPD patients, and its different characteristics in amplitude, frequency and waveform can be analyzed by intelligent algorithms for the auxiliary diagnosis of COPD. The current study is to conduct external clinical validation of COPD auxiliary diagnosis algorithm and lung function prediction algorithm, and preliminatively verify the performance of the algorithm, with the ultimate goal of developing a portable and rapid COPD auxiliary diagnosis and condition assessment tool that can be used at home.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2023-09
• Study First Submitted: 2023-10-08
• Study First Submitted QC: 2023-10-08
• Last Update Submitted: 2023-10-08
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• patients with stable COPD were recruited for this study. Inclusion criteria were age ≥40 years and a diagnosis of COPD

Exclusion Criteria

• Exclusion criteria were acute exacerbations of respiratory symptoms within the past 2 weeks or significant comorbid cardiovascular, neurological, musculoskeletal, immunological, or infectious diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive Agreement Rate (PPA)	12.30.2024	Positive Agreement Rate (PPA) of auxiliary Diagnosis Algorithm for COPD

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China