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OpenTrials
Completed

NCT Number: NCT05776654

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Chronic Obstructive Pulmonary Disease Exacerbation Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Biometric wearable devices

Device

Passive data collection using biometric wearable devices.

Primary outcomes

  1. Daily symptom score

    Time frame: Daily for 21 days

    Validated AECOPD symptom score (EXACT PRO) will serve as the dependent (outcome) variable.

  2. 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.

Secondary outcomes

  1. Daily/nightly heart rate and HR variability

    Time frame: Daily for 21 days

    HR and HRV will serve as secondary independent (predictor) variables.

  2. Daily/nightly peripheral body temperature

    Time frame: Daily for 21 days

    Temperature will serve as secondary independent (predictor) variables.

  3. Activity

    Time frame: Daily for 21 days

    Activity parameters (including calories, METS, step count, etc.) will serve as secondary independent (predictor) variables.

  4. Sleep metrics

    Time frame: 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.

  5. Autonomic function/Stress

    Time frame: Daily for 21 days

    Metrics of stress/autonomic function (including electrodermal activity) will serve as secondary independent (predictor) variables.

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2023
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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