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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05776654

Enrollment

Registered

2023-03-20

Start date

2023-02-16

Completion date

2024-01-15

Last updated

2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Exacerbation

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.

Interventions

DEVICEBiometric wearable devices

Passive data collection using biometric wearable devices.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Daily symptom score	Daily for 21 days	Validated AECOPD symptom score (EXACT PRO) will serve as the dependent (outcome) variable.
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.

Secondary

Measure	Time frame	Description
Activity	Daily for 21 days	Activity parameters (including calories, METS, step count, 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.
Autonomic function/Stress	Daily for 21 days	Metrics of stress/autonomic function (including electrodermal activity) 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 peripheral body temperature	Daily for 21 days	Temperature will serve as secondary independent (predictor) variables.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026