NCT06802003 Predicting Acute Exacerbations of COPD Using Wearable Devices and Remote Monitoring Technology With AI/ML Models
| NCT ID | NCT06802003 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | COPD |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-05-22 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06802003 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06802003 currently recruiting?
Yes, NCT06802003 is actively recruiting participants. Contact the research team at bryan.ross@mcgill.ca for enrollment information.
Where is the NCT06802003 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06802003 clinical trial?
NCT06802003 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 50 participants.
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