Evaluate the Accuracy of a COPD Screening Algorithm Model

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06109974
• Other study ID #: 2022083-20230810
• Status: Completed
• Start date: September 13, 2022
• Est. completion date: January 4, 2024

Study information

• Verified date: January 2024
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 4, 2024
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
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	Shichahai community health service center	Beijing	Beijing
China	The Hospital of Changping District Beijing	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Peking University First Hospital	Baizhifang Community Health Service Center of Xicheng District Beijing, Civil Aviation General Hospital, Shichahai Community Health Service Center of Xicheng District Beijing, The Hospital of Changping District Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic accuracy of the algorithm for COPD	The diagnostic accuracy of the algorithm for COPD	1 year
Secondary	The diagnostic sensitivity and specificity of the algorithm	The diagnostic sensitivity and specificity of the algorithm	1 year
Secondary	The diagnostic accuracy of COPD-PS score for COPD	The diagnostic accuracy of COPD-PS score for COPD	1 year