Upper Airway Stimulation for Obstructive Sleep Apnea : Patient-Reported Outcomes after 48 Months of Follow-up

Objective. To assess patient-based outcomes of participants in a large cohort study-the STAR trial (Stimulation Therapy for Apnea Reduction)-48 months after implantation with an upper airway stimulation system for moderate to severe obstructive sleep apnea. Study Design. A multicenter prospective cohort study. Setting. Industry-supported multicenter academic and clinical setting. Subjects. Participants (n = 91) at 48 months from a cohort of 126 implanted participants. Methods. A total of 126 participants received an implanted upper airway stimulation system in a prospective phase III trial. Patient-reported outcomes at 48 months, including Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and snoring level, were compared with preimplantation baseline. Results. A total of 91 subjects completed the 48-month visit. Daytime sleepiness as measured by ESS was significantly reduced (P = .01), and sleep-related quality of life as measured by FOSQ significantly improved (P = .01) when compared with baseline. Soft to no snoring was reported by 85% of bed partners. Two patients required additional surgery without complication for lead malfunction. Conclusion. Upper airway stimulation maintained a sustained benefit on patient-reported outcomes (ESS, FOSQ, snoring) at 48 months in select patients with moderate to severe obstructive sleep apnea.