Evaluate the Accuracy of a COPD Screening Algorithm Model

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-13

Study Completion Date

2024-01-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory diseases. Early detection and treatment are critical to prevent the deterioration of COPD. In this study, we have established an algorithm that can detect and infer the severity of COPD from physiological parameters and audio data collected by wearable devices, and in this stage, we aim to evaluate the accuracy of this algorithm.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Detect and Infer the Severity of COPD by Intelligent Terminal Device

NCT05551169

COPD

COMPLETED

The Cohort Study for Chronic Obstructive Pulmonary Disease (COPD) in China

NCT03044847

Pulmonary Disease, Chronic Obstructive

ENROLLING_BY_INVITATION

The China National COPD Screening Program

NCT05480176

Chronic Obstructive Pulmonary Disease

RECRUITING

Study on the Etiology, Risk Factors and Pathogenesis of COPD Based on Clinical Bioinformatics

NCT05069194

Chronic Obstructive Pulmonary Disease

UNKNOWN

Validation of Chronic Obstructive Pulmonary Disease (COPD) Algorithm

NCT07223749

COPD (Chronic Obstructive Pulmonary Disease)

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators have established an algorithm that can detect COPD from physiological parameters, coughing sounds, and forceful expiratory sounds collected by wearable devices. This study will test the accuracy of this algorithm.

In this study, 404 residents at high risk of COPD (COPD-PS score≥5) will be enrolled. Questionnaires related to COPD will be collected, subjects will undergo pulmonary function tests and electrocardiogram. Physiological parameters such as oxygen saturation and heart rate will be collected by a wearable device 3 times for 2 minutes each time, and coughing sound will be collected. As spirometry is the gold standard for the diagnosis of COPD, the accuracy of COPD diagnosis algorithm model by intelligent terminal devices will be verified.

The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2022-083). Any protocol modifications will be submitted for the IRB review and approval.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants with high risk of COPD

no intervention

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Over the age of 18, no gender restrictions.
2. Participants at high risk of COPD (COPD-PS score ≥5).
3. Able to carry out daily activities and wear wearable devices.
4. Willing to participate in the study, willing to comply with the study protocol, and have the ability to sign informed consent.
5. Possess mobile communication equipment, which can meet the requirement of installing wearable device applications and recording function.

Exclusion Criteria

1. Diagnosed with chronic respiratory diseases other than COPD, such as asthma, lung cancer, active tuberculosis, bronchiectasis and diffuse lung diseases (interstitial pneumonia, occupational lung disease, sarcoidosis, etc.).
2. lobectomy and/or lung transplantation, pleural disease.
3. Complicated with serious underlying diseases, including severe mental illness, intellectually impaired diseases, neurological disease (resulting in limb movement disorder), malignant tumor (PS score \> 2), chronic liver disease (transaminase \> 3 times the upper limit of normal), heart failure (NYHA\> Grade 3), autoimmune disease, chronic kidney disease (CKD-5), unstable coronary artery disease, arrhythmia (atrial fibrillation, atrial flutter, severe ventricular arrhythmia), congenital heart disease, pulmonary hypertension, etc., or life expectancy of less than 6 months.
4. Malnutrition (BMI\<18 kg/m2).
5. Bilateral wrist and hand edema, wrist soft tissue injury, inability to wear a watch/bracelet due to incomplete skin.
6. Dual upper limb pigmentation or abnormal blood supply (occlusion, thrombosis, trauma, etc.).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No