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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Characterizing the Recovery Phase of Acute Exacerbations of COPD Using Wearable Remote Monitoring Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05776654
• Other study ID #: 2023-8851
• Status: Completed
• Start date: February 16, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: February 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Chronic Obstructive Pulmonary Disease Exacerbation
• Disease Progression
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Biometric wearable devices
Passive data collection using biometric wearable devices.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily symptom score	Validated AECOPD symptom score (EXACT PRO) will serve as the dependent (outcome) variable.	Daily for 21 days
Primary	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.	Daily for 21 days
Secondary	Daily/nightly heart rate and HR variability	HR and HRV will serve as secondary independent (predictor) variables.	Daily for 21 days
Secondary	Daily/nightly peripheral body temperature	Temperature will serve as secondary independent (predictor) variables.	Daily for 21 days
Secondary	Activity	Activity parameters (including calories, METS, step count, etc.) will serve as secondary independent (predictor) variables.	Daily for 21 days
Secondary	Sleep metrics	Sleep metrics (including rem and non-rem stages of sleep; sleep duration, latency, efficiency, etc.) will serve as secondary independent (predictor) variables.	Daily (nightly) for 21 days.
Secondary	Autonomic function/Stress	Metrics of stress/autonomic function (including electrodermal activity) will serve as secondary independent (predictor) variables.	Daily for 21 days