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Evaluate the Accuracy of a COPD Screening Algorithm Model

Evaluation of an Algorithm That Can Detect COPD by Intelligent Terminal Device

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06109974
Enrollment
400
Registered
2023-10-31
Start date
2022-09-13
Completion date
2024-01-04
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, Intelligent Terminal Device, Algorithm model

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Civil Aviation General Hospital
CollaboratorOTHER
Shichahai Community Health Service Center of Xicheng District Beijing
CollaboratorUNKNOWN
The Hospital of Changping District Beijing
CollaboratorUNKNOWN
Baizhifang Community Health Service Center of Xicheng District Beijing
CollaboratorUNKNOWN
Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.).

Design outcomes

Primary

MeasureTime frameDescription
The diagnostic accuracy of the algorithm for COPD1 yearThe diagnostic accuracy of the algorithm for COPD

Secondary

MeasureTime frameDescription
The diagnostic sensitivity and specificity of the algorithm1 yearThe diagnostic sensitivity and specificity of the algorithm
The diagnostic accuracy of COPD-PS score for COPD1 yearThe diagnostic accuracy of COPD-PS score for COPD

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026