Detect and Infer the Severity of COPD by Intelligent Terminal Device

Establishment of an Algorithm That Can Detect and Infer the Severity Level of 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, investigators aim to develop an algorithm that can detect and infer the severity level of COPD from physiological parameters and audio data which are collected by a wearable device. Investigators will complete the study in two stages: stage 1. A panel study to assess the ability to infer the severity of COPD by intelligent terminal devices; stage 2. Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices.

Study Overview

• Status: Completed
• Conditions: COPD

Detailed Description

In this study, investigators aim to establish an algorithm that can detect and infer the severity level of COPD from physiological parameters, coughing sounds, and forceful blowing sounds data that are collected by wearable devices.

This study is divided into two stages. Stage one: A panel study to assess the ability to infer the severity of COPD by intelligent terminal devices. 30 patients with stable COPD will be enrolled and will undergo pulmonary function tests, electrocardiogram, echocardiography measurement, blood gas analysis, six-minutes walking test (6MWT), and polysomnography. And they are required to fill in the questionnaires related to COPD every day. Physiological parameters including oxygen saturation, heart rate, sleep, and physical activity will be collected by a wearable device for 7-14 consecutive days. Coughing and forceful blowing sounds will be collected twice daily. The association between the severity of COPD and physiological parameters from the wearable device will be analyzed.

Stage two: Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices. 200 patients with stable COPD and 200 non- COPD subjects will be enrolled. Questionnaires related to COPD will be collected, and subjects will undergo pulmonary function tests and electrocardiograms. Physiological parameters including oxygen saturation and heart rate will be continuously collected by a wearable device for about 3～7 days. Investigators will also collect coughing and forceful blowing sounds. A COPD diagnosis algorithm model based on physiological parameters and audio data of intelligent terminal devices will be established.

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 IRB review and approval.

• Study Type: Observational
• Enrollment (Actual): 432

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Civil Aviation General Hospital
    • Beijing, Beijing, China
      • Peking University Shougang Hospital
    • Beijing, Beijing, China
      • Aerospace 731 Hospital
    • Beijing, Beijing, China
      • Beijing Jingmei Group General Hospital
    • Beijing, Beijing, China
      • Beijing Jishuitan Hospital
    • Beijing, Beijing, China
      • Beijing Luhe Hospital
    • Beijing, Beijing, China
      • Beijing Miyun Hospital
    • Beijing, Beijing, China
      • People's Hospital of Beijing Daxing District
    • Beijing, Beijing, China
      • The Hospital of Shunyi District Beijing
    • Beijing, Beijing, China
      • Shichahai community health service center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Stage I: patients with stable COPD Stage 2: patients with stable COPD and non-COPD subjects

Description

Stage 1:

Inclusion criteria:

1. Older than 18 years old, no gender limitation;
2. In COPD stable stage (if there is an acute exacerbation, patients should be enrolled 3 months after remission of the exacerbation);
3. Be able to carry out daily activities and wear wearable devices;
4. Have willing to participate in this study and comply with the study protocol, and can sign informed consent;
5. Possess mobile communication equipment, which can meet the requirement of installing wearable device APP, and have a recording function.

Exclusion criteria:

1. Have been diagnosed with chronic respiratory diseases other than COPD, such as bronchial 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 > Normal high limit 3 times), heart failure (NYHA> Grade 3), autoimmune disease, chronic kidney disease (CKD-5), unstable coronary heart disease, arrhythmias (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, can not wear a watch/bracelet because of the incompleted skin;
6. Double upper limb pigmentation or abnormal blood supply (occlusion, thrombosis, trauma, etc.) Stage 2 COPD group: Patients with stable COPD（same inclusion and exclusion criteria as Stage 1） Control group: healthy non-COPD population whose lung function must meet: FEV1/ FVC > 0.7, FEV1 > Pred 80% after bronchial dilation test when they are enrolled;

Inclusion criteria:

1. Older than 18 years old;
2. Be able to carry out daily activities and wear wearable devices;
3. Have willing to participate in this study and comply with the study protocol, and can sign informed consent;
4. Possess mobile communication devices, which can meet the requirements of installing wearable devices APP, and have a recording function.

Exclusion criteria: COPD and other serious chronic diseases (same exclusion criteria as COPD group).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients with stable COPD in Stage1; no intervention
Patients with stable COPD in Stage2; no intervention
Non-COPD subjects in Stage2; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage 1: Association between the severity of COPD airflow restriction and data collected by wearable devices	Association between the severity of COPD airflow restriction and data collected by wearable devices	2 months
Stage 2：Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices	Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage 1: The compliance of subjects with wearable devices	The compliance of subjects with wearable devices is defined as the percentage of the actual completion time of data collection to the minimum required time (10 hours X 7 days=70 hours).	2 months
Stage 1: Association between the severity of COPD airflow restriction, CAT score, mMRC score, echocardiography, blood gas analysis, six-minutes walking distance, polysomnography，and data collected by wearable devices	Association between the severity of COPD airflow restriction, CAT score, mMRC score, echocardiography, blood gas analysis, six-minutes walking distance, polysomnography，and data collected by wearable devices	2 months
Stage 2: Association between the severity of COPD airflow restriction, CAT score, mMRC score，and data collected by wearable devices	Association between the severity of COPD airflow restriction, CAT score, mMRC score，and data collected by wearable devices	5 months
Stage 2: number of adverse events	The number of adverse events	5 months

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Peking University Shougang Hospital; Beijing Jishuitan Hospital; Beijing Luhe Hospital; Civil Aviation General Hospital; People's Hospital of Beijing Daxing District; Aerospace 731 Hospital; The Hospital of Shunyi District Beijing; Beijing Jingmei Group General Hospital; Beijing Miyun Hospital; Shichahai community health service center
• Investigators: Study Chair: Guangfa Wang, MD, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: September 17, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Intelligent Terminal Device; Algorithm model
• Other Study ID Numbers: 2022083-0624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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