title: Upper Airway Stimulation for Obstructive Sleep Apnea: Patient-Reported Outcomes after 48 Months of Follow-up.
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.
authors.affiliation: 1 University of Tennessee, Memphis, Tennessee, USA.
authors.forename: M Boyd
authors.initials: MB
authors.lastname: Gillespie
authors.affiliation: 2 School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Ryan J
authors.initials: RJ
authors.lastname: Soose
authors.affiliation: 3 Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
authors.forename: B Tucker
authors.initials: BT
authors.lastname: Woodson
authors.affiliation: 4 Case Western Reserve University, Cleveland, Ohio, USA.
authors.forename: Kingman P
authors.initials: KP
authors.lastname: Strohl
authors.affiliation: 5 University Hospital Mannheim, Mannheim, Germany.
authors.forename: Joachim T
authors.initials: JT
authors.lastname: Maurer
authors.affiliation: 6 OLVG Hospital and ACTA, Amsterdam, Netherlands.
authors.forename: Nico
authors.initials: N
authors.lastname: de Vries
authors.affiliation: 7 University of Cincinnati Medical Center, Cincinnati, Ohio, USA.
authors.forename: David L
authors.initials: DL
authors.lastname: Steward
authors.affiliation: 4 Case Western Reserve University, Cleveland, Ohio, USA.
authors.forename: Jonathan Z
authors.initials: JZ
authors.lastname: Baskin
authors.affiliation: 8 Wayne State University, Detroit, Michigan, USA.
authors.forename: M Safwan
authors.initials: MS
authors.lastname: Badr
authors.affiliation: 8 Wayne State University, Detroit, Michigan, USA.
authors.forename: Ho-Sheng
authors.initials: HS
authors.lastname: Lin
authors.affiliation: 9 University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: Tapan A
authors.initials: TA
authors.lastname: Padhya
authors.affiliation: 10 Advanced ENT, Atlanta, Georgia, USA.
authors.forename: Sam
authors.initials: S
authors.lastname: Mickelson
authors.affiliation: 9 University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: W McDowell
authors.initials: WM
authors.lastname: Anderson
authors.affiliation: 11 Antwerp University Hospital, Edegem, Belgium.
authors.forename: Olivier M
authors.initials: OM
authors.lastname: Vanderveken
authors.affiliation: 2 School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Strollo
mesh_terms: D006970:Disorders of Excessive Somnolence / Q000628:therapy; D004599:Electric Stimulation Therapy; D005500:Follow-Up Studies; D006801:Humans; D007002:Hypoglossal Nerve; D058542:Implantable Neurostimulators; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011446:Prospective Studies; D011788:Quality of Life; D057566:Self Report; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D012913:Snoring / Q000628:therapy
keywords: apnea hypopnea index; clinical; cranial nerve; device; hypoglossal nerve; implant; long term; obstructive sleep apnea; quality of life; sleep