STAR study of Inspire UAS System (Inspire Medical Systems) shows benefits for Obstructive Sleep Apnea
Electronic stimulation therapy to reduce Obstructive Sleep Apnea (OSA) is safe and effective, according to results from the STAR Trial which evaluated the Inspire Upper Airway Stimulation System, from Inspire Medical Systems. This therapy is designed to deliver mild stimulation to the main nerve of the tongue (hypoglossal nerve) on each breathing cycle during sleep. The stimulation is intended to restore tone to key airway muscles and prevent airway collapse.
The multi-center study had 126 participants (21 females) who received an implanted system. At 12 months, there was a significant reduction in the Apnea Hypopnea Index (AHI) and Oxygen Desaturation Index, two scales used to indicate the severity of OSA. There also were significant improvements from pre-implant to 12 months on sleep quality scales (Epworth Sleepiness Scale, ESS, and Functional Outcome of Sleep Questionnaire, FOSQ). Results of the STAR trial data have been submitted to the FDA for review and consideration for approval.