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.