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

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06082791
Collaborator
(none)
500
Enrollment
1
Location
18
Anticipated Duration (Months)
27.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Clinical Validation Study to Evaluate the Diagnostic Accuracy of a Cough-based Auxiliary Diagnosis Algorithm for Chronic Obstructive Pulmonary Disease (COPD)
    Actual Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Dec 30, 2023
    Anticipated Study Completion Date :
    Dec 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    COPD
    other respiratory disease without COPD
    healthy people without respiratory disease

    Outcome Measures

    Primary Outcome Measures

    1. Positive Agreement Rate (PPA) [12.30.2024]

      Positive Agreement Rate (PPA) of auxiliary Diagnosis Algorithm for COPD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200000

    Sponsors and Collaborators

    • Ruijin Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT06082791
    Other Study ID Numbers:
    • 2023-199
    First Posted:
    Oct 13, 2023
    Last Update Posted:
    Oct 13, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cough

    Study Results

    No Results Posted as of Oct 13, 2023