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

October 8, 2023 updated by: Ruijin Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

three cohorts are included COPD respiratory disease without cold healthy people

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
COPD
other respiratory disease without COPD
healthy people without respiratory disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Agreement Rate (PPA)
Time Frame: 12.30.2024
Positive Agreement Rate (PPA) of auxiliary Diagnosis Algorithm for COPD
12.30.2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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