Using wearable devices to monitor COPD deterioration

Early Warning Value of Consumer Wearable Devices in Chronic Obstructive Pulmonary Disease Exacerbation: An Evaluation Study

This study is testing whether wearable devices can help people with stable COPD track their health and predict when their symptoms might get worse.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 35 Years to 80 Years
• Sex: All
• Sponsor: Peking University First Hospital (other)
• Locations: 7 sites (Beijing, Beijing and 6 other locations)
• Trial ID: NCT05974670 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of consumer wearable devices in monitoring physiological parameters of patients with stable Chronic Obstructive Pulmonary Disease (COPD). A total of 150 participants aged 35 to 80 will wear these devices to continuously collect data on metrics such as pulse rate, blood oxygen saturation, and physical activity. Participants will also maintain a daily COPD symptom diary and undergo follow-ups at specified intervals. The goal is to establish a model that predicts acute exacerbations of COPD based on the collected data.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 35 to 80 with a diagnosis of stable COPD and the ability to use a mobile phone for data collection.

Not a fit: Patients with a history of asthma, lung cancer, or other serious underlying diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enable early detection of COPD exacerbations, leading to timely interventions and improved patient outcomes.

How similar studies have performed: While the use of wearable devices in chronic disease management is gaining traction, this specific approach to COPD monitoring is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Patients diagnosed with stable COPD (refer to 2021 GOLD guidelines);
* Age between 35 and 80 years (both 35 and 80), either gender;
* A post-bronchodilator forced expiratory volume in 1 second percentage (FEV1%) predicted between 25%\~80%;
* Having mobile phone which can install APP of wearable device;
* Able to engage in daily activities;

Exclusion Criteria:

* History of asthma, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease;
* History of lobectomy and/or lung transplantation;
* Predicted life expectancy less than 3 years;
* History of serious underlying diseases (including severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease);
* Alcoholism, drug or toxic solvents abuse;
* Moderate to severe anemia;
* Smoking or quitting smoking for less than 6 weeks;
* Skin pigmentation, deformity, arterial stenosis or occlusion of both upper limbs;
* Skin allergy to metal/plastic;
* Those who are participating in other clinical trials, cannot be followed up for a long time or have poor compliance.

Where this trial is running

Beijing, Beijing and 6 other locations

• Peking University First Hospital — Beijing, Beijing, China (RECRUITING)
• Aerospace 731 Hospital — Beijing, Beijing, China (NOT_YET_RECRUITING)
• Beijing Miyun Hospital — Beijing, Beijing, China (NOT_YET_RECRUITING)
• Civil Aviation General Hospital — Beijing, Beijing, China (NOT_YET_RECRUITING)
• People's Hospital of Beijing Daxing District — Beijing, Beijing, China (NOT_YET_RECRUITING)
• Shichahai Community Health Service Center — Beijing, Beijing, China (NOT_YET_RECRUITING)
• The Hospital of Shunyi District Beijing — Beijing, Beijing, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Jiping Liao, MD.

Conditions: COPD, AECOPD, Consumer wearable device