An observational study in Chronic Obstructive Pulmonary Disease and Chronic Obstructive Pulmonary Disease Exacerbation, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 21 is below the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with COPD currently experiencing an exacerbation.
Exclusion Criteria:
Patients with COPD currently experiencing and receiving treatment for an exacerbation.
Device: Biometric wearable devices
Passive data collection using biometric wearable devices.
Daily symptom score
Validated AECOPD symptom score (EXACT PRO) will serve as the dependent (outcome) variable.
Time frame: 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.
Time frame: Daily for 21 days
Daily/nightly heart rate and HR variability
HR and HRV will serve as secondary independent (predictor) variables.
Time frame: Daily for 21 days
Daily/nightly peripheral body temperature
Temperature will serve as secondary independent (predictor) variables.
Time frame: Daily for 21 days
Activity
Activity parameters (including calories, METS, step count, etc.) will serve as secondary independent (predictor) variables.
Time frame: 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.
Time frame: Daily (nightly) for 21 days.
Autonomic function/Stress
Metrics of stress/autonomic function (including electrodermal activity) will serve as secondary independent (predictor) variables.
Time frame: Daily for 21 days
Plan to share: 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).
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre