A Randomized Crossover Study Evaluating the Feasibility and Usability of the Easy Breather in Subjects with Chronic Obstructive Respiratory Disease Grant uri icon

Abstract

  • The Easy Breather (EB) is a manually-powered, non-invasive, durable and mechanical device designed to lessen breathing difficulties associated with COPD and serve as an adjunct therapy for COPD management. A potential advantage of the EB is that it is designed for home use. However, the device has never been tested for feasibility or usability among people with COPD. The primary objective of this pilot study is to assess the feasibility and usability of the EB in people with COPD. To inform this objective, changes in health status measured by the COPD Clinical Questionnaire (CCQ)19 will be evaluated with and without use of the EB as an adjunct to standard care. A crossover design will be used to assess changes in CCQ scores during a 4-week period of daily EB use in addition to the individual’s standard care (EB+SC), compared to 4 weeks of standard care alone (SC). The crossover design is used to control for a wide range of potential confounders (e.g., COPD severity, medications) as each subject serves as his or her own control.

Date/time Interval

  • 2016-01-01 - 2016-05-01

Date Filed

  • 2015-10-01

Total Award Amount

  • 5000