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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
McGill University Health Centre
RECRUITING
Montreal
Contact Information
Primary
Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)
bryan.ross@mcgill.ca
(514) 843-1465
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 50
Sponsors
Collaborators: Restech Srl
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov