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.
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.
Study Type
OBSERVATIONAL
Enrollment
50
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).
McGill University Health Centre
Montreal, Quebec, Canada
RECRUITINGRespiration
Respiratory rate (RR) and respiratory rate variability (RRV) measured with wearable devices
Time frame: Daily/nightly for 12 months
Cardiovascular
Heart rate (HR) and HR variability (HRV) measured with wearable devices
Time frame: Daily/nightly for 12 months
Oxygen level
Blood oxygen saturation (SpO2) measured with wearable devices
Time frame: Daily/nightly for 12 months
Step count
Parameter measured with wearable devices, related to activity.
Time frame: Daily/nightly for 12 months
Sleep duration
Parameter measured with wearable devices.
Time frame: Nightly for 12 months
Rapid eye movement (REM) sleep
Parameter measured with wearable devices.
Time frame: Nightly for 12 months
Deep sleep
Parameter measured with wearable devices.
Time frame: Nightly for 12 months
Body temperature
Peripheral body temperature measured with wearable devices
Time frame: Nightly for 12 months
Resistance at 5 Hz (R5)
Parameter measured at 5 Hz frequency with handheld oscillometry, related to lung mechanics/function.
Time frame: Daily for 12 months
Reactance at 5 Hz (X5)
Parameter measured at 5 Hz frequency with handheld oscillometry, related to lung mechanics/function.
Time frame: Daily for 12 months
Intra-breath difference between expiratory and inspiratory reactance (ΔXrs)
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Time frame: Daily for 12 months
Tidal volume (Vt)
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Time frame: Daily for 12 months
Respiratory flows
Inspiratory and expiratory flows measured with handheld oscillometry, related to lung mechanics/function.
Time frame: Daily for 12 months
Respiratory rate (RR)
Parameter measured with handheld oscillometry.
Time frame: Daily for 12 months
Minute ventilation (Ve)
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Time frame: Daily for 12 months
Heart rate (HR) prior oscillometry test
Parameter measured with handheld oscillometry before performing oscillometry test.
Time frame: Daily for 12 months
Blood oxygen saturation (SpO2) prior oscillometry test
Parameter measured with handheld oscillometry before performing oscillometry test.
Time frame: Daily for 12 months
Daily symptom questionnaire
• Visual analog scale (VAS) scores for dyspnea, sputum volume, sputum purulence, cough, wheeze, and fatigue, scaled 0-10. Higher scores indicate worse symptoms.
Time frame: Daily for 12 months
Weekly exacerbation questionnaire
• Self report on any exacerbation(s) which occurred in the preceding week and their date(s), whether/how the exacerbation was treated, and in what treatment setting.
Time frame: Weekly for 12 months
Calories
Parameter measured with wearable devices, related to activity.
Time frame: Daily/nightly for 12 months
Metabolic equivalents
Parameter measured with wearable devices, related to activity.
Time frame: Daily/nightly for 12 months
Movement intensity
Parameter measured with wearable devices, related to activity.
Time frame: Daily/nightly for 12 months
Sleep efficiency
Parameter measured with wearable devices.
Time frame: Nightly for 12 months
Sleep oncet
Parameter measured with wearable devices.
Time frame: Nightly for 12 months
Sleep disturbance
Parameter measured with wearable devices.
Time frame: Nightly for 12 months
COPD Assessment Test (CAT)
Validated COPD questionnaire consisting of 8 questions and scaled 0-40. Higher scores indicate the severity of disease impact.
Time frame: Once (baseline visit)
6-Minute Walk Test (6MWT)
Standard and validated assessment in COPD. Outcomes include distance walked as well as heart rate (HR), oxygen saturation (SpO2), and respiratory rate (RR) during the test. the 6MWT will be performed once at baseline while the participant is wearing the biometric wearable devices.
Time frame: Once (baseline visit)
System Usability Scale (SUS)
Practical and reliable tool to determine the user experience with a variety of systems and devices. Scaled from 1-5, higher scores indicate better experience.
Time frame: Through study completion, 1 year.
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