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Upper Airway Stimulation for Obstructive Sleep Apnea: Patient-Reported Outcomes after 48 Months of Follow-up. Otolaryngol Head Neck Surg 2017 Apr;156(4):765-771

Date

02/15/2017

Pubmed ID

28194999

DOI

10.1177/0194599817691491

Scopus ID

2-s2.0-85018995158 (requires institutional sign-in at Scopus site)   73 Citations

Abstract

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.

Author List

Gillespie MB, Soose RJ, Woodson BT, Strohl KP, Maurer JT, de Vries N, Steward DL, Baskin JZ, Badr MS, Lin HS, Padhya TA, Mickelson S, Anderson WM, Vanderveken OM, Strollo PJ Jr, STAR Trial Investigators

Author

B Tucker Woodson MD Chief, Professor in the Otolaryngology department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Disorders of Excessive Somnolence
Electric Stimulation Therapy
Follow-Up Studies
Humans
Hypoglossal Nerve
Implantable Neurostimulators
Male
Middle Aged
Patient Reported Outcome Measures
Prospective Studies
Quality of Life
Self Report
Sleep Apnea, Obstructive
Snoring