Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

Massachusetts General Hospital20 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

COPD Exacerbation Copd

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Sufficient understanding of the English language to be able to read and understand study procedures. Exclusion Criteria: 1. Currently on admission in the hospital, on non-invasive positive airway pressure ventilation 2. Visual, hearing or cognitive impairments at the discretion of their physician. 3. Currently participating in a COPD telemonitoring program. 4. No AT\&T cellular coverage at their primary residence 5. 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.

Locations (1)

Partners Connected Health

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Daily, 16 weeks

Secondary Outcomes

Oxygen saturation (%)

Collected via pulse oximeter.

Time frame: 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

Time frame: Weekly for16 weeks

Physical activity

Collected via step counts

Time frame: Daily for 16 weeks

Body Mass Index (kg/m^2)

Weight and height will be combined to report BMI

Time frame: Baseline (Day 0) and Close-out (16 weeks)

Quality of life

Collected via SF-12 questionnaire

Time frame: Baseline (Day 0) and Close-out (16 weeks)

Depression

Collected via PHQ-8 questionnaire

Time frame: Monthly for 16 weeks

Anxiety

Collected via GAD-7 questionnaire

Time frame: Baseline (Day 0) and Close-out (16 weeks)

COPD symptom assessment

Data from ClinicalTrials.gov

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