Recruiting

Observational Study

Sponsor:

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

Code:

NCT06802003

Conditions

COPD

AE COPD

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Biometric wearable and handheld devices

Study Details

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.

Conditions

COPD

AE COPD

Study ID

NCT06802003

Start date

May 22, 2025

Status verified date

May, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 measure

  • 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 ]
  • Intra-breath difference between expiratory and inspiratory reactance (ΔXrs) [ Time Frame: Daily for 12 months ]
  • Tidal volume (Vt) [ Time Frame: Daily for 12 months ]
  • Respiratory flows [ Time Frame: Daily for 12 months ]
  • Respiratory rate (RR) [ Time Frame: Daily for 12 months ]
  • Minute ventilation (Ve) [ Time Frame: Daily for 12 months ]
  • Heart rate (HR) prior oscillometry test [ Time Frame: Daily for 12 months ]
  • Blood oxygen saturation (SpO2) prior oscillometry test [ Time Frame: Daily for 12 months ]
  • Daily symptom questionnaire [ Time Frame: Daily for 12 months ]
  • Weekly exacerbation questionnaire [ Time Frame: Weekly for 12 months ]
  • Calories [ Time Frame: Daily/nightly for 12 months ]
  • Metabolic equivalents [ Time Frame: Daily/nightly for 12 months ]
  • Movement intensity [ Time Frame: Daily/nightly for 12 months ]
  • Sleep efficiency [ Time Frame: Nightly for 12 months ]
  • Sleep oncet [ Time Frame: Nightly for 12 months ]
  • Sleep disturbance [ Time Frame: Nightly for 12 months ]

Central Contacts and Locations

Central contacts

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

(514) 843-1465bryan.ross@mcgill.ca

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Bryan A. Ross

(514) 843-1465bryan.ross@mcgill.ca

More Information

Sponsor

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

Last update posted

May 28, 2025

Last verified

May, 2025

Keywords

  • acute exacerbation of COPD (AECOPD)
  • chronic obstructive pulmonary disease (COPD)
  • artificial intelligence/machine learning (AI/ML)
  • remote patient monitoring (RPM)
  • biometric wearable device
  • oscillometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-05-28.