RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - Ability to access internet at least once daily Who Should NOT Join This Trial: - No existing COPD diagnosis - Any medical/cognitive/functional condition which renders inability to operate research equipment/devices, and/or to complete daily symptom response Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Biometric 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).

Locations (1)

McGill University Health Centre

Montreal, Quebec, Canada