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NCT Number: NCT06802003

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

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.

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Key information

Conditions

COPD AE COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location status: Recruiting

Location contact

Bryan A. Ross

CONTACT

[email protected]

(514) 843-1465

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biometric wearable and handheld devices

Device

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 outcomes

  1. Respiration

    Time frame: Daily/nightly for 12 months

    Respiratory rate (RR) and respiratory rate variability (RRV) measured with wearable devices

  2. Cardiovascular

    Time frame: Daily/nightly for 12 months

    Heart rate (HR) and HR variability (HRV) measured with wearable devices

  3. Oxygen level

    Time frame: Daily/nightly for 12 months

    Blood oxygen saturation (SpO2) measured with wearable devices

  4. Step count

    Time frame: Daily/nightly for 12 months

    Parameter measured with wearable devices, related to activity.

  5. Sleep duration

    Time frame: Nightly for 12 months

    Parameter measured with wearable devices.

  6. Rapid eye movement (REM) sleep

    Time frame: Nightly for 12 months

    Parameter measured with wearable devices.

  7. Deep sleep

    Time frame: Nightly for 12 months

    Parameter measured with wearable devices.

  8. Body temperature

    Time frame: Nightly for 12 months

    Peripheral body temperature measured with wearable devices

  9. Resistance at 5 Hz (R5)

    Time frame: Daily for 12 months

    Parameter measured at 5 Hz frequency with handheld oscillometry, related to lung mechanics/function.

  10. Reactance at 5 Hz (X5)

    Time frame: Daily for 12 months

    Parameter measured at 5 Hz frequency with handheld oscillometry, related to lung mechanics/function.

  11. Intra-breath difference between expiratory and inspiratory reactance (ΔXrs)

    Time frame: Daily for 12 months

    Parameter measured with handheld oscillometry, related to lung mechanics/function.

  12. Tidal volume (Vt)

    Time frame: Daily for 12 months

    Parameter measured with handheld oscillometry, related to lung mechanics/function.

  13. Respiratory flows

    Time frame: Daily for 12 months

    Inspiratory and expiratory flows measured with handheld oscillometry, related to lung mechanics/function.

  14. Respiratory rate (RR)

    Time frame: Daily for 12 months

    Parameter measured with handheld oscillometry.

  15. Minute ventilation (Ve)

    Time frame: Daily for 12 months

    Parameter measured with handheld oscillometry, related to lung mechanics/function.

  16. Heart rate (HR) prior oscillometry test

    Time frame: Daily for 12 months

    Parameter measured with handheld oscillometry before performing oscillometry test.

  17. Blood oxygen saturation (SpO2) prior oscillometry test

    Time frame: Daily for 12 months

    Parameter measured with handheld oscillometry before performing oscillometry test.

  18. Daily symptom questionnaire

    Time frame: Daily for 12 months

    • Visual analog scale (VAS) scores for dyspnea, sputum volume, sputum purulence, cough, wheeze, and fatigue, scaled 0-10. Higher scores indicate worse symptoms.

  19. Weekly exacerbation questionnaire

    Time frame: Weekly for 12 months

    • 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.

  20. Calories

    Time frame: Daily/nightly for 12 months

    Parameter measured with wearable devices, related to activity.

  21. Metabolic equivalents

    Time frame: Daily/nightly for 12 months

    Parameter measured with wearable devices, related to activity.

  22. Movement intensity

    Time frame: Daily/nightly for 12 months

    Parameter measured with wearable devices, related to activity.

  23. Sleep efficiency

    Time frame: Nightly for 12 months

    Parameter measured with wearable devices.

  24. Sleep oncet

    Time frame: Nightly for 12 months

    Parameter measured with wearable devices.

  25. Sleep disturbance

    Time frame: Nightly for 12 months

    Parameter measured with wearable devices.

Secondary outcomes

  1. COPD Assessment Test (CAT)

    Time frame: Once (baseline visit)

    Validated COPD questionnaire consisting of 8 questions and scaled 0-40. Higher scores indicate the severity of disease impact.

  2. 6-Minute Walk Test (6MWT)

    Time frame: Once (baseline visit)

    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.

  3. System Usability Scale (SUS)

    Time frame: Through study completion, 1 year.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)

CONTACT

[email protected]

(514) 843-1465

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Restech Srl

Registry information

Official study title

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

Acronym: ePredictAECOPD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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