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NCT Number: NCT06109974

Evaluate the Accuracy of a COPD Screening Algorithm Model

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baizhifang Community Health Service Center of Xicheng District Beijing, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.).

Treatment and study plan

Primary outcomes

  1. The diagnostic accuracy of the algorithm for COPD

    Time frame: 1 year

    The diagnostic accuracy of the algorithm for COPD

Secondary outcomes

  1. The diagnostic sensitivity and specificity of the algorithm

    Time frame: 1 year

    The diagnostic sensitivity and specificity of the algorithm

  2. The diagnostic accuracy of COPD-PS score for COPD

    Time frame: 1 year

    The diagnostic accuracy of COPD-PS score for COPD

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2023
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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