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

May 22, 2025 updated by: Bryan A. Ross, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)
  • Phone Number: (514) 843-1465
  • Email: bryan.ross@mcgill.ca

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Respiration
Time Frame: Daily/nightly for 12 months
Respiratory rate (RR) and respiratory rate variability (RRV) measured with wearable devices
Daily/nightly for 12 months
Cardiovascular
Time Frame: Daily/nightly for 12 months
Heart rate (HR) and HR variability (HRV) measured with wearable devices
Daily/nightly for 12 months
Oxygen level
Time Frame: Daily/nightly for 12 months
Blood oxygen saturation (SpO2) measured with wearable devices
Daily/nightly for 12 months
Step count
Time Frame: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Daily/nightly for 12 months
Sleep duration
Time Frame: Nightly for 12 months
Parameter measured with wearable devices.
Nightly for 12 months
Rapid eye movement (REM) sleep
Time Frame: Nightly for 12 months
Parameter measured with wearable devices.
Nightly for 12 months
Deep sleep
Time Frame: Nightly for 12 months
Parameter measured with wearable devices.
Nightly for 12 months
Body temperature
Time Frame: Nightly for 12 months
Peripheral body temperature measured with wearable devices
Nightly for 12 months
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.
Daily for 12 months
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.
Daily for 12 months
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.
Daily for 12 months
Tidal volume (Vt)
Time Frame: Daily for 12 months
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Daily for 12 months
Respiratory flows
Time Frame: Daily for 12 months
Inspiratory and expiratory flows measured with handheld oscillometry, related to lung mechanics/function.
Daily for 12 months
Respiratory rate (RR)
Time Frame: Daily for 12 months
Parameter measured with handheld oscillometry.
Daily for 12 months
Minute ventilation (Ve)
Time Frame: Daily for 12 months
Parameter measured with handheld oscillometry, related to lung mechanics/function.
Daily for 12 months
Heart rate (HR) prior oscillometry test
Time Frame: Daily for 12 months
Parameter measured with handheld oscillometry before performing oscillometry test.
Daily for 12 months
Blood oxygen saturation (SpO2) prior oscillometry test
Time Frame: Daily for 12 months
Parameter measured with handheld oscillometry before performing oscillometry test.
Daily for 12 months
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.
Daily for 12 months
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.
Weekly for 12 months
Calories
Time Frame: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Daily/nightly for 12 months
Metabolic equivalents
Time Frame: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Daily/nightly for 12 months
Movement intensity
Time Frame: Daily/nightly for 12 months
Parameter measured with wearable devices, related to activity.
Daily/nightly for 12 months
Sleep efficiency
Time Frame: Nightly for 12 months
Parameter measured with wearable devices.
Nightly for 12 months
Sleep oncet
Time Frame: Nightly for 12 months
Parameter measured with wearable devices.
Nightly for 12 months
Sleep disturbance
Time Frame: Nightly for 12 months
Parameter measured with wearable devices.
Nightly for 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Once (baseline visit)
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.
Once (baseline visit)
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.
Through study completion, 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Restech Srl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-10606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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