Chronic Obstructive Pulmonary DiseaseNCT05776654
Wearable Devices in the Recovery Phase of Acute Exacerbations of COPD (AECOPDs)
An observational study of Chronic Obstructive Pulmonary Disease and Chronic Obstructive Pulmonary Disease Exacerbation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose the study is to successfully characterize the recovery phase of acute exacerbations of COPD in the outpatient setting using remotely captured physiologic data from wearable devices, to compare this with patient self-reported symptom data, to determine which physiologic variable(s) best correspond with… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Exacerbation
- What is being tested?
- Biometric wearable devices
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 16 Feb 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 currently experiencing an exacerbation.
Who may be able to join
- Males/females, age ≥40, former/current smokers with ≥10 pack-year smoking history
- Currently experiencing/receiving treatment for a physician-diagnosed AECOPD
- Forced expired volume in the first second (FEV1) / Forced vital capacity (FVC) < 0.7 (GOLD 1-4)
- Ability to provide informed consent
Who cannot join
- No existing COPD diagnosis
- History of cardiac arrhythmia
- Presence of pacemaker/defibrillator
- Any medical/cognitive/functional condition which renders inability to don/doff/recharge devices and complete symptom questionnaire
- Have already received 4 or more days of consecutive corticosteroid and/or antibiotic therapy since presenting to medical attention for their AECOPD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing the Recovery Phase of Acute Exacerbations of COPD Using Wearable Remote Monitoring Technology
The purpose the study is to successfully characterize the recovery phase of acute exacerbations of COPD in the outpatient setting using remotely captured physiologic data from wearable devices, to compare this with patient self-reported symptom data, to determine which physiologic variable(s) best correspond with AECOPD recovery, and to further document the feasibility, data quantity, data quality, and COPD outpatient usability experience with wearable devices.
- Being tested
- Biometric wearable devices
- 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 devicesDevice
Passive data collection using biometric wearable devices.
| Study group | Role | What they receive |
|---|---|---|
| COPD cohort | Patients with COPD currently experiencing and receiving treatment for an exacerbation. Receives: Device: Biometric wearable devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily symptom score
Validated AECOPD symptom score (EXACT PRO) will serve as the dependent (outcome) variable.
Measured: Daily for 21 days
Daily/nightly respiration
Respiratory rate (RR) will serve as the primary independent (predictor) variable, and RR variability will serve as a secondary independent (predictor) variable.
Measured: Daily for 21 days
Secondary outcomes (5)
Daily/nightly heart rate and HR variability
HR and HRV will serve as secondary independent (predictor) variables.
Measured: Daily for 21 days
Daily/nightly peripheral body temperature
Temperature will serve as secondary independent (predictor) variables.
Measured: Daily for 21 days
Activity
Activity parameters (including calories, METS, step count, etc.) will serve as secondary independent (predictor) variables.
Measured: Daily for 21 days
Sleep metrics
Sleep metrics (including rem and non-rem stages of sleep; sleep duration, latency, efficiency, etc.) will serve as secondary independent (predictor) variables.
Measured: Daily (nightly) for 21 days.
Autonomic function/Stress
Metrics of stress/autonomic function (including electrodermal activity) will serve as secondary independent (predictor) variables.
Measured: Daily for 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start16 Feb 2023
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Ross, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Bryan A. Ross, MD, FRCPC, MSc (Epi, Physiol), Principal investigator, Research Institute of the McGill University Health Centre (RI-MUHC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776654
- Sponsor's protocol ID
- 2023-8851
- Status last verified
- May 2024
- First submitted
- 16 Feb 2023
- Last updated
- 29 May 2024
- 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 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Recovery Phase of Acute Exacerbations of COPD Using Wearable Remote Monitoring Technology
- ClinicalTrials.gov ID
- NCT05776654
- Acronym / sponsor ID
- 2023-8851
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 20 Mar 2023 (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.
The purpose the study is to successfully characterize the recovery phase of acute exacerbations of COPD in the outpatient setting using remotely captured physiologic data from wearable devices, to compare this with patient self-reported symptom data, to determine which physiologic variable(s) best correspond with AECOPD recovery, and to further document the feasibility, data quantity, data quality, and COPD outpatient usability experience with wearable devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD cohort | – | Device: Biometric wearable devicesPatients with COPD currently experiencing and receiving treatment for an exacerbation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD currently experiencing an exacerbation.
Key inclusion criteria (4 listed)
- Males/females, age ≥40, former/current smokers with ≥10 pack-year smoking history
- Currently experiencing/receiving treatment for a physician-diagnosed AECOPD
- Forced expired volume in the first second (FEV1) / Forced vital capacity (FVC) < 0.7 (GOLD 1-4)
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- No existing COPD diagnosis
- History of cardiac arrhythmia
- Presence of pacemaker/defibrillator
- Any medical/cognitive/functional condition which renders inability to don/doff/recharge devices and complete symptom questionnaire
- Have already received 4 or more days of consecutive corticosteroid and/or antibiotic therapy since presenting to medical attention for their AECOPD
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 devicesPassive data collection using biometric wearable devices. | Device | COPD cohort |
Primary outcome
Daily symptom score
Time frame: Daily for 21 days
Validated AECOPD symptom score (EXACT PRO) will serve as the dependent (outcome) variable.
Daily/nightly respiration
Time frame: Daily for 21 days
Respiratory rate (RR) will serve as the primary independent (predictor) variable, and RR variability will serve as a secondary independent (predictor) variable.
5 secondary outcomes
Daily/nightly heart rate and HR variability
Time frame: Daily for 21 days
Daily/nightly peripheral body temperature
Time frame: Daily for 21 days
Activity
Time frame: Daily for 21 days
Sleep metrics
Time frame: Daily (nightly) for 21 days.
Autonomic function/Stress
Time frame: Daily for 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- 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. This study is not recruiting at the moment.
Bryan A. Ross, MD, FRCPC, MSc (Epi, Physiol) principal investigator
Research Institute of the McGill University Health Centre (RI-MUHC)
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 Chronic Obstructive Pulmonary Disease and Chronic Obstructive Pulmonary Disease Exacerbation, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily symptom score (time frame: Daily for 21 days). The study lists 2 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 29 May 2024.