Partners Connected Health
Boston, Massachusetts, 02114, United States
NCT Number: NCT03300739
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.
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Notify Me18 year and older
All sexes
Observational
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Daily for 16 weeks
Collected via pulse oximeter.
Time frame: Weekly for16 weeks
Collected via spirometer
Time frame: Daily for 16 weeks
Collected via step counts
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Weight and height will be combined to report BMI
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Collected via SF-12 questionnaire
Time frame: Monthly for 16 weeks
Collected via PHQ-8 questionnaire
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Collected via GAD-7 questionnaire
Time frame: Weekly for 16 weeks
Collected via CAT questionnaire
Time frame: Weekly for 16 weeks
Collected via mMRC dyspnea scale
Time frame: Close-out (16 week)
Collected via usability questionnaire
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Collected via electronic health record
Time frame: Baseline (Day 0) and Close-out (16 weeks)
Collected via electronic health record
Massachusetts General Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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