NCT05974670

Early Warning Value of Consumer Wearable Devices in AECOPD

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center cohort study. 150 subjects with COPD and in stable stage will be included. Wearable device's physiological parameters will be continually collected, the investigators aim to explore whether consumer wearable devices are useful for early warning deterioration of COPD.

Detailed description

This is a prospective cohort study. 150 subjects aged 35～80y with stable COPD will be recruited. After enrollment, subjects wear consumer wearable devices and install APP on their mobile phones. The first 7 days of wearing are to evaluate the stability of data collection and the subject compliance, and to correct the wrong wearing. The subjects are required to fill in the COPD symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Primary outcome is the moderate or more severe COPD acute exacerbation events. The purpose of this study is to use consumer wearable devices to monitor the changes of COPD, and to establish a physiological parameters model of wearable device that can predict the acute exacerbation of COPD. The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2021-397). Any protocol modifications will be submitted for the IRB review and approval.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	Consumer wearable device	The subjects are required to wear the consumer wearable devices continuously during the whole study period. The device can provided several physiological parameters, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep.

Timeline

• Start date: 2022-06-21
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2023-08-03
• Last updated: 2023-08-03

Locations

7 sites across 1 country: China