An observational study in COPD Exacerbation and Copd, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-30.
Sponsored by Massachusetts General Hospital · Observational
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.
Patients with COPD diagnosis
Exclusion Criteria:
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
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
Collected via CAT questionnaire
Time frame: Weekly for 16 weeks
Functional impairment due to dyspnea
Collected via mMRC dyspnea scale
Time frame: Weekly for 16 weeks
Study device usability
Collected via usability questionnaire
Time frame: Close-out (16 week)
Medical treatment
Collected via electronic health record
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Hospitalization records
Collected via electronic health record
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital