Evaluate the Accuracy of a COPD Screening Algorithm Model

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

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.

Study Overview

• Status: Completed
• Conditions: COPD

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Shichahai community health service center
    • Beijing, Beijing, China
      • Baizhifang Community Health Service Center of Xicheng District Beijing
    • Beijing, Beijing, China
      • Civil Aviation General Hospita
    • Beijing, Beijing, China
      • Guangfa Wang
    • Beijing, Beijing, China
      • The Hospital of Changping District Beijing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

participants at high risk of COPD

Description

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.).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with high risk of COPD; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic accuracy of the algorithm for COPD	The diagnostic accuracy of the algorithm for COPD	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic sensitivity and specificity of the algorithm	The diagnostic sensitivity and specificity of the algorithm	1 year
The diagnostic accuracy of COPD-PS score for COPD	The diagnostic accuracy of COPD-PS score for COPD	1 year

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Civil Aviation General Hospital; Shichahai Community Health Service Center of Xicheng District Beijing; The Hospital of Changping District Beijing; Baizhifang Community Health Service Center of Xicheng District Beijing
• Investigators: Study Chair: Guangfa Wang, MD, Peking University first hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Intelligent Terminal Device; Algorithm model
• Other Study ID Numbers: 2022083-20230810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No