COPDePredictAECOPDNCT06802003
Predicting Acute Exacerbations of COPD Using Wearable Devices and Remote Monitoring Technology With AI/ML Models
An observational study of COPD and AE COPD, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- What is being tested?
- Biometric wearable and handheld devices
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 22 May 2025to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD with a documented history of frequent exacerbations. While there is no specific method to estimate sample sizes for machine learning-based clinical research, based on two prior COPD studies measuring respiratory rate (RR) differences between stable-state and peak exacerbation phases, it was estimated that detecting a 4 breaths/min difference in RR (effect size 0.74) requires 17 prospectively collected exacerbation events, with alpha set to 0.05, power set to 0.8, and two-tailed analysis. Detecting a more subtle difference (i.e. 2 breaths/min; effect size 0.36) would require 63 events. Assuming each participant experiences two exacerbations annually, 32 participants would meet these requirements. To account for the long observation period, the potential for non-events, and a 25% attrition rate, up to 50 participants will be recruited for this one-year study.
Who may be able to join
- 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
Who cannot join
- No existing COPD diagnosis
- Any medical/cognitive/functional condition which renders inability to operate research equipment/devices, and/or to complete daily symptom response
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Bryan A. Ross, (514) 843-1465, bryan.ross@mcgill.ca
About this study
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
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.
Read the 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.
- Being tested
- Biometric wearable and handheld devices
- 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biometric wearable and handheld devicesDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiration
Respiratory rate (RR) and respiratory rate variability (RRV) measured with wearable devices
Measured: Daily/nightly for 12 months
Cardiovascular
Heart rate (HR) and HR variability (HRV) measured with wearable devices
Measured: Daily/nightly for 12 months
Oxygen level
Blood oxygen saturation (SpO2) measured with wearable devices
Measured: Daily/nightly for 12 months
Step count
Parameter measured with wearable devices, related to activity.
Measured: Daily/nightly for 12 months
Sleep duration
Parameter measured with wearable devices.
Measured: Nightly for 12 months
Rapid eye movement (REM) sleep
Parameter measured with wearable devices.
Measured: Nightly for 12 months
Deep sleep
Parameter measured with wearable devices.
Measured: Nightly for 12 months
Body temperature
Peripheral body temperature measured with wearable devices
Measured: Nightly for 12 months
Resistance at 5 Hz (R5)
Parameter measured at 5 Hz frequency with handheld oscillometry, related to lung mechanics/function.
Measured: Daily for 12 months
Reactance at 5 Hz (X5)
Parameter measured at 5 Hz frequency with handheld oscillometry, related to lung mechanics/function.
Measured: Daily for 12 months
Intra-breath difference between expiratory and inspiratory reactance (ΔXrs)
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Measured: Daily for 12 months
Tidal volume (Vt)
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Measured: Daily for 12 months
Respiratory flows
Inspiratory and expiratory flows measured with handheld oscillometry, related to lung mechanics/function.
Measured: Daily for 12 months
Respiratory rate (RR)
Parameter measured with handheld oscillometry.
Measured: Daily for 12 months
Minute ventilation (Ve)
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Measured: Daily for 12 months
Heart rate (HR) prior oscillometry test
Parameter measured with handheld oscillometry before performing oscillometry test.
Measured: Daily for 12 months
Blood oxygen saturation (SpO2) prior oscillometry test
Parameter measured with handheld oscillometry before performing oscillometry test.
Measured: 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.
Measured: 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.
Measured: Weekly for 12 months
Calories
Parameter measured with wearable devices, related to activity.
Measured: Daily/nightly for 12 months
Metabolic equivalents
Parameter measured with wearable devices, related to activity.
Measured: Daily/nightly for 12 months
Movement intensity
Parameter measured with wearable devices, related to activity.
Measured: Daily/nightly for 12 months
Sleep efficiency
Parameter measured with wearable devices.
Measured: Nightly for 12 months
Sleep oncet
Parameter measured with wearable devices.
Measured: Nightly for 12 months
Sleep disturbance
Parameter measured with wearable devices.
Measured: Nightly for 12 months
Secondary outcomes (3)
COPD Assessment Test (CAT)
Validated COPD questionnaire consisting of 8 questions and scaled 0-40. Higher scores indicate the severity of disease impact.
Measured: 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.
Measured: 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.
Measured: Through study completion, 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start22 May 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Restech Srl
- Responsible party
- Principal investigator, Bryan A. Ross, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802003
- Sponsor's protocol ID
- 2025-10606
- Other IDs
- 2025
- Acronym
- ePredictAECOPD
- Status last verified
- May 2025
- First submitted
- 25 Jan 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data privacy regulations, individual participant data collected during this study is not publicly accessible. However, access to anonymized data may be granted upon evaluation by the trial management group. Additional documents will also be available upon inquiry. All requests should be directed to the corresponding author (BAR).
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06802003
- Acronym / sponsor ID
- ePredictAECOPD / 2025-10606
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Restech Srl
- Study start
- 22 May 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD with a documented history of frequent exacerbations. While there is no specific method to estimate sample sizes for machine learning-based clinical research, based on two prior COPD studies measuring respiratory rate (RR) differences between stable-state and peak exacerbation phases, it was estimated that detecting a 4 breaths/min difference in RR (effect size 0.74) requires 17 prospectively collected exacerbation events, with alpha set to 0.05, power set to 0.8, and two-tailed analysis. Detecting a more subtle difference (i.e. 2 breaths/min; effect size 0.36) would require 63 events. Assuming each participant experiences two exacerbations annually, 32 participants would meet these requirements. To account for the long observation period, the potential for non-events, and a 25% attrition rate, up to 50 participants will be recruited for this one-year study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- No existing COPD diagnosis
- Any medical/cognitive/functional condition which renders inability to operate research equipment/devices, and/or to complete daily symptom response
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biometric wearable and handheld devicesIn 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). | Device | – |
Primary outcome
Respiration
Time frame: Daily/nightly for 12 months
Respiratory rate (RR) and respiratory rate variability (RRV) measured with wearable devices
Cardiovascular
Time frame: Daily/nightly for 12 months
Heart rate (HR) and HR variability (HRV) measured with wearable devices
Oxygen level
Time frame: Daily/nightly for 12 months
Blood oxygen saturation (SpO2) measured with wearable devices
Step count
Time frame: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Sleep duration
Time frame: Nightly for 12 months
Parameter measured with wearable devices.
Rapid eye movement (REM) sleep
Time frame: Nightly for 12 months
Parameter measured with wearable devices.
Deep sleep
Time frame: Nightly for 12 months
Parameter measured with wearable devices.
Body temperature
Time frame: Nightly for 12 months
Peripheral body temperature measured with wearable devices
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.
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.
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.
Tidal volume (Vt)
Time frame: Daily for 12 months
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Respiratory flows
Time frame: Daily for 12 months
Inspiratory and expiratory flows measured with handheld oscillometry, related to lung mechanics/function.
Respiratory rate (RR)
Time frame: Daily for 12 months
Parameter measured with handheld oscillometry.
Minute ventilation (Ve)
Time frame: Daily for 12 months
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Heart rate (HR) prior oscillometry test
Time frame: Daily for 12 months
Parameter measured with handheld oscillometry before performing oscillometry test.
Blood oxygen saturation (SpO2) prior oscillometry test
Time frame: Daily for 12 months
Parameter measured with handheld oscillometry before performing oscillometry test.
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.
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.
Calories
Time frame: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Metabolic equivalents
Time frame: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Movement intensity
Time frame: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Sleep efficiency
Time frame: Nightly for 12 months
Parameter measured with wearable devices.
Sleep oncet
Time frame: Nightly for 12 months
Parameter measured with wearable devices.
Sleep disturbance
Time frame: Nightly for 12 months
Parameter measured with wearable devices.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No. Due to data privacy regulations, individual participant data collected during this study is not publicly accessible. However, access to anonymized data may be granted upon evaluation by the trial management group. Additional documents will also be available upon inquiry. All requests should be directed to the corresponding author (BAR).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and AE COPD, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan A. Ross, MD, MSc (Physiol), MSc (Epi) ((514) 843-1465, bryan.ross@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiration (time frame: Daily/nightly for 12 months). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.