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Recruiting NCT06802003

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

— Observational COPD AE COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biometric wearable and handheld devices.
Who it may be relevant to
Registry conditions: COPD, AE COPD. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

A single-site, prospective, observational cohort study to collect high-quality multidimensional data from the wearable/portable devices, as well as symptom and exacerbation data, in high-risk patients with frequent exacerbations in order to develop a COPD exacerbation predictive model.

Interventions

  • 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).

Primary outcome measures

  • Respiration [Time frame: Daily/nightly for 12 months]
  • Cardiovascular [Time frame: Daily/nightly for 12 months]
  • Oxygen level [Time frame: Daily/nightly for 12 months]
  • Step count [Time frame: Daily/nightly for 12 months]
  • Sleep duration [Time frame: Nightly for 12 months]
  • Rapid eye movement (REM) sleep [Time frame: Nightly for 12 months]
  • Deep sleep [Time frame: Nightly for 12 months]
  • Body temperature [Time frame: Nightly for 12 months]
  • Resistance at 5 Hz (R5) [Time frame: Daily for 12 months]
  • Reactance at 5 Hz (X5) [Time frame: Daily for 12 months]
Secondary outcome measures (3)
  • COPD Assessment Test (CAT) [Time frame: Once (baseline visit)]
  • 6-Minute Walk Test (6MWT) [Time frame: Once (baseline visit)]
  • System Usability Scale (SUS) [Time frame: Through study completion, 1 year.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • McGill University Health Centre — Montreal

Identifiers

NCT: NCT06802003 · 2025-10606

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗