RecruitingNCT06802003

Predicting Acute Exacerbations of COPD Using Wearable Devices and Remote Monitoring Technology With AI/ML Models

Early Prediction of Acute Exacerbations of COPD Using Wearable and Portable Remote Monitoring Technology With AI/ML Empowered Platforms: A Prospective Clinical Study

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

50 participants

Start Date

May 22, 2025

Study Type

OBSERVATIONAL

Conditions

COPD AE COPD

Summary

This study is aimed to collect real-time physiological data using two wearable devices (a biometric ring and a biometric wristband), daily lung mechanical measurements by a handheld oscillometer, and participant-reported symptoms in patients with COPD remotely from their home environment. The data will be used to train and validate artificial intelligence and machine learning (AI/ML) models to predict COPD exacerbations in advance of their actual occurrence. The data will also be used to test the new severity classification system for exacerbations of COPD, as well as to determine important relationships between physiological measurements from the wearable devices, the handheld oscillometer, the self-reported symptoms, and the tests performed at the baseline visit.

Eligibility

Min Age: 40 Years

Inclusion Criteria5

Males/females, age ≥ 40, former/current smokers with ≥10 pack-year smoking history
FEV1/FVC \< 0.7, with 80% \< FEV1 ≤50% (moderate, 'GOLD 2') 50% \< FEV1 ≤ 30% (severe, 'GOLD 3') or FEV1 \< 30% (very severe, 'GOLD 4') COPD
History of 2 or more exacerbations in the preceding 12 months requiring corticosteroids, antibiotics, or both
Ability to provide informed consent
Ability to access internet at least once daily

Exclusion Criteria2

No existing COPD diagnosis
Any medical/cognitive/functional condition which renders inability to operate research equipment/devices, and/or to complete daily symptom response

Interventions

DEVICEBiometric wearable and handheld devices

In this study, participants will be equipped with biometric wearable devices, i.e. ring and wristband, as well as with a handheld oscillometer, to measure their physiological parameters and lung mechanical changes (lung function).