NCT03300739

Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD Exacerbation
• Copd

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-02-01
• Completion: 2019-09-01
• First posted: 2017-10-03
• Last updated: 2020-09-30

Locations

1 site across 1 country: United States