Status:

COMPLETED

Evaluate the Accuracy of a COPD Screening Algorithm Model

Lead Sponsor:

Peking University First Hospital

Collaborating Sponsors:

Civil Aviation General Hospital

Shichahai Community Health Service Center of Xicheng District Beijing

Conditions:

COPD

Eligibility:

All Genders

18+ years

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 est...

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.).
  • lobectomy and/or lung transplantation, pleural disease.
  • 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.
  • Malnutrition (BMI\<18 kg/m2).
  • Bilateral wrist and hand edema, wrist soft tissue injury, inability to wear a watch/bracelet due to incomplete skin.
  • Dual upper limb pigmentation or abnormal blood supply (occlusion, thrombosis, trauma, etc.).

Key Trial Info

Start Date :

September 13 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 4 2024

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT06109974

Start Date

September 13 2022

End Date

January 4 2024

Last Update

January 23 2024

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Baizhifang Community Health Service Center of Xicheng District Beijing

Beijing, Beijing Municipality, China

2

Civil Aviation General Hospita

Beijing, Beijing Municipality, China

3

Guangfa Wang

Beijing, Beijing Municipality, China

4

Shichahai community health service center

Beijing, Beijing Municipality, China