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NCT06082791 Clinical Trial

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

COPD Clinical Trial

Official title:
A Clinical Validation Study to Evaluate the Diagnostic Accuracy of a Cough-based Auxiliary Diagnosis Algorithm for Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06082791
Other study ID # 2023-199
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date December 30, 2024

Study information
Verified date September 2023
Source Ruijin Hospital
Contact Jiemin QU, pHD
Phone 15390460355
Email 15390460355@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Positive Agreement Rate (PPA) Positive Agreement Rate (PPA) of auxiliary Diagnosis Algorithm for COPD 12.30.2024
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