Wearable Devices in the Recovery Phase of Acute Exacerbations of COPD (AECOPDs)

Completed

• Conditions: Chronic Obstructive Pulmonary Disease Exacerbation; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT05776654
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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 AECOPD recovery, and to further document the feasibility, data quantity, data quality, and COPD outpatient usability experience with wearable devices.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-16
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-20
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-26
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Males/females, age ≥40, former/current smokers with ≥10 pack-year smoking history
2. Currently experiencing/receiving treatment for a physician-diagnosed AECOPD
3. Forced expired volume in the first second (FEV1) / Forced vital capacity (FVC) < 0.7 (GOLD 1-4)
4. Ability to provide informed consent

Exclusion Criteria

1. No existing COPD diagnosis
2. History of cardiac arrhythmia
3. Presence of pacemaker/defibrillator
4. Any medical/cognitive/functional condition which renders inability to don/doff/recharge devices and complete symptom questionnaire
5. Have already received 4 or more days of consecutive corticosteroid and/or antibiotic therapy since presenting to medical attention for their AECOPD

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily/nightly respiration	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.
Daily symptom score	Daily for 21 days	Validated AECOPD symptom score (EXACT PRO) will serve as the dependent (outcome) variable.

Secondary Outcome Measures

Name	Time	Method
Daily/nightly peripheral body temperature	Daily for 21 days	Temperature will serve as secondary independent (predictor) variables.
Sleep metrics	Daily (nightly) for 21 days.	Sleep metrics (including rem and non-rem stages of sleep; sleep duration, latency, efficiency, etc.) will serve as secondary independent (predictor) variables.
Daily/nightly heart rate and HR variability	Daily for 21 days	HR and HRV will serve as secondary independent (predictor) variables.
Activity	Daily for 21 days	Activity parameters (including calories, METS, step count, etc.) will serve as secondary independent (predictor) variables.
Autonomic function/Stress	Daily for 21 days	Metrics of stress/autonomic function (including electrodermal activity) will serve as secondary independent (predictor) variables.

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada