Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

Study Overview
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Brief Summary
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This is an observational pilot study focused on collecting data on clinical variables that can improve the understanding of potential predictors of disease exacerbation and readmissions in COPD patients. The study aim is to understand how the variability of clinical parameters (respiratory rate, forced expiratory volume in one second, and oxygen saturation), physical activity and quality of life is associated with the risk of exacerbation in COPD patients.

Detailed Description
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The investigational product to be used in this trial is the ResMed Biomotion Sensor (ResMed Sensor Technologies, Dublin, Ireland). This device uses very low power radio waves ( 1/100th of the strength of a mobile phone signal) to detect respiratory movements of a person while asleep- without physical contact with the individual. The device is designed to measure up to 5 feet, so that only the person on the side of the bed nearest the device is monitored. Algorithms have been developed to analyze the respiratory movement signals and extract information about respiration rate, bodily movements, sleep/wake patterns and sleep disordered respiration.

Official Title
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Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

Conditions
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Copd, COPD Exacerbation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically stable and ambulatory COPD (primary diagnosis) patients who have had an emergency room visit or hospitalization for an acute exacerbation of COPD within the past 30 days. Sufficient understanding of the English language to be able to read and understand study procedures. Exclusion Criteria: Currently on admission in the hospital, on non-invasive positive airway pressure ventilation Visual, hearing or cognitive impairments at the discretion of their physician. Currently participating in a COPD telemonitoring program. No AT&T cellular coverage at their primary residence Any other medical or psychological condition that, in the opinion of the investigator may present an unreasonable risk to the study participant as a result of his/her participation in this study, may make participant's participation unreliable, or may interfere with study assessments.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate (breaths per minute) | Collected by study device, Reassure Respiration Monitor. This device uses very low power radio waves to detect respiratory movements of a person while asleep. | Daily, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation (%) | Collected via pulse oximeter. | Daily for 16 weeks | 
| Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second. | Collected via spirometer | Weekly for16 weeks | 
| Physical activity | Collected via step counts | Daily for 16 weeks | 
| Body Mass Index (kg/m^2) | Weight and height will be combined to report BMI | Baseline (Day 0) and Close-out (16 weeks) | 
| Quality of life | Collected via SF-12 questionnaire | Baseline (Day 0) and Close-out (16 weeks) | 
| Depression | Collected via PHQ-8 questionnaire | Monthly for 16 weeks | 
| Anxiety | Collected via GAD-7 questionnaire | Baseline (Day 0) and Close-out (16 weeks) | 
| COPD symptom assessment | Collected via CAT questionnaire | Weekly for 16 weeks | 
| Functional impairment due to dyspnea | Collected via mMRC dyspnea scale | Weekly for 16 weeks | 
| Study device usability | Collected via usability questionnaire | Close-out (16 week) | 
| Medical treatment | Collected via electronic health record | Baseline (Day 0) and Close-out (16 weeks) | 
| Hospitalization records | Collected via electronic health record | Baseline (Day 0) and Close-out (16 weeks) |