title: Three-Year Outcomes of Cranial Nerve Stimulation for Obstructive Sleep Apnea: The STAR Trial.
abstract: OBJECTIVE
  To describe the 36-month clinical and polysomnography (PSG) outcomes in an obstructive sleep apnea (OSA) cohort treated with hypoglossal cranial nerve upper airway stimulation (UAS).
  
  
  METHODS
  A multicenter prospective cohort study.
  
  
  METHODS
  Industry-supported multicenter academic and clinical setting.
  
  
  METHODS
  Participants (n = 116) at 36 months from a cohort of 126 implanted participants.
  
  
  METHODS
  Participants were enrolled in a prospective phase III trial evaluating the efficacy of UAS for moderated to severe OSA. Prospective outcomes included apnea-hypopnea index, oxygen desaturation index, other PSG measures, self-reported measures of sleepiness, sleep-related quality of life, and snoring.
  
  
  RESULTS
  Of 126 enrolled participants, 116 (92%) completed 36-month follow-up evaluation per protocol; 98 participants additionally agreed to a voluntary 36-month PSG. Self-report daily device usage was 81%. In the PSG group, 74% met the a priori definition of success with the primary outcomes of apnea-hypopnea index, reduced from the median value of 28.2 events per hour at baseline to 8.7 and 6.2 at 12 and 36 months, respectively. Similarly, self-reported outcomes improved from baseline to 12 months and were maintained at 36 months. Soft or no snoring reported by bed partner increased from 17% at baseline to 80% at 36 months. Serious device-related adverse events were rare, with 1 elective device explantation from 12 to 36 months.
  
  
  CONCLUSIONS
  Long-term 3-year improvements in objective respiratory and subjective quality-of-life outcome measures are maintained. Adverse events are uncommon. UAS is a successful and appropriate long-term treatment for individuals with moderate to severe OSA.
authors.affiliation: Medical College of Wisconsin, Milwaukee, Wisconsin, USA bwoodson@mcw.edu.
authors.forename: B Tucker
authors.initials: BT
authors.lastname: Woodson
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
authors.forename: Ryan J
authors.initials: RJ
authors.lastname: Soose
authors.affiliation: Medical University of South Carolina, Charleston, South Carolina, USA.
authors.forename: M Boyd
authors.initials: MB
authors.lastname: Gillespie
authors.affiliation: Case Western Reserve University, Cleveland, Ohio, USA.
authors.forename: Kingman P
authors.initials: KP
authors.lastname: Strohl
authors.affiliation: University Hospital Mannheim, Mannheim, Germany.
authors.forename: Joachim T
authors.initials: JT
authors.lastname: Maurer
authors.affiliation: Saint Lucas Andreas Hospital, Amsterdam, Netherlands.
authors.forename: Nico
authors.initials: N
authors.lastname: de Vries
authors.affiliation: University of Cincinnati Medical Center, Cincinnati, Ohio, USA.
authors.forename: David L
authors.initials: DL
authors.lastname: Steward
authors.affiliation: Case Western Reserve University, Cleveland, Ohio, USA.
authors.forename: Jonathan Z
authors.initials: JZ
authors.lastname: Baskin
authors.affiliation: Wayne State University, Detroit, Michigan, USA.
authors.forename: M Safwan
authors.initials: MS
authors.lastname: Badr
authors.affiliation: Wayne State University, Detroit, Michigan, USA.
authors.forename: Ho-sheng
authors.initials: HS
authors.lastname: Lin
authors.affiliation: University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: Tapan A
authors.initials: TA
authors.lastname: Padhya
authors.affiliation: Advanced ENT, Atlanta, Georgia, USA.
authors.forename: Sam
authors.initials: S
authors.lastname: Mickelson
authors.affiliation: University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: W McDowell
authors.initials: WM
authors.lastname: Anderson
authors.affiliation: Antwerp University Hospital, Edegem, Belgium.
authors.forename: Olivier M
authors.initials: OM
authors.lastname: Vanderveken
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Strollo
mesh_terms: D015331:Cohort Studies; D003391:Cranial Nerves; D004599:Electric Stimulation Therapy; D005260:Female; D006801:Humans; D058542:Implantable Neurostimulators; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
keywords: apnea hypopnea index; clinical; cranial nerve; device; hypoglossal nerve; implant; long term; obstructive sleep apnea; quality of life; sleep