Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Respiratory rate (breaths per minute)
Study Overview
Brief Summary
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
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Respiratory rate (breaths per minute)
Time Frame: Daily, 16 weeks
Collected by study device, Reassure Respiration Monitor. This device uses very low power radio waves to detect respiratory movements of a person while asleep.
Secondary Outcomes
- Depression(Monthly for 16 weeks)
- Oxygen saturation (%)(Daily for 16 weeks)
- Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second.(Weekly for16 weeks)
- Quality of life(Baseline (Day 0) and Close-out (16 weeks))
- COPD symptom assessment(Weekly for 16 weeks)
- Physical activity(Daily for 16 weeks)
- Body Mass Index (kg/m^2)(Baseline (Day 0) and Close-out (16 weeks))
- Anxiety(Baseline (Day 0) and Close-out (16 weeks))
- Functional impairment due to dyspnea(Weekly for 16 weeks)
- Medical treatment(Baseline (Day 0) and Close-out (16 weeks))
- Hospitalization records(Baseline (Day 0) and Close-out (16 weeks))
- Study device usability(Close-out (16 week))
Investigators
Joseph C. Kvedar
Dermatologist
Massachusetts General Hospital