Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:10/5/2017
Start Date:December 2016
End Date:May 2018
Contact:Yunmi Shin
Email:yshin3@partners.org
Phone:617-643-0198

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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.

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.

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.
We found this trial at
1
site
25 New Chardon Street
Boston, Massachusetts 02114
Phone: 617-643-0198
?
mi
from
Boston, MA
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