Inspire® Upper Airway Stimulation (UAS) System: Post Approval Study
WIRB® Protocol #20150855
Today, many people are affected by obstructive sleep apnea, also known as OSA, where their airways are blocked during sleep so they can't breathe. There are several types of therapy options for those who have OSA, however many people cannot tolerate these options. Inspire Medical Systems has developed a device called the Inspire Upper Airway System (Inspire system), that is implanted inside the body and will stimulate the nerve under the chin to hold the airway open during sleep. By stimulating the nerve under the chin, called the hypoglossal nerve, with mild electrical stimulation, a patient's tongue is lifted up from the back of the throat, which can hold open the airway in carefully selected patients.
The Inspire system, and the procedure to implant the Inspire system, has been approved for market release in the United States (U.S.) and in Europe. Although these approvals have been received, the U.S. Food and Drug Administration (FDA) has required that Inspire Medical Systems conduct an additional clinical trial to gather more information.
The purpose of this study is to continue gathering information on how the device works in a "real world" setting. In addition, the information gathered will continue to educate physicians who treat OSA.
You may qualify for this study if you have moderate to severe OSA that has not been effectively treated with CPAP.
In addition to the standard clinic visits required for screening, implant and follow-up care for Inspire therapy, during this study you will be seen periodically by your study doctor to gather quality of life data (how you are doing with daily aspects of your life) and your thoughts on your therapy experience. All implanted patients will be followed for 5 years following surgery.
You will receive reimbursement if you qualify for implant and participate in this study.
Beth Duddy, RN, CCRC