title: Upper Airway Stimulation for Obstructive Sleep Apnea: Durability of the Treatment Effect at 18 Months.
abstract: OBJECTIVE
  To determine the stability of improvement in polysomnographic measures of sleep disordered breathing, patient reported outcomes, the durability of hypoglossal nerve recruitment and safety at 18 months in the Stimulation Treatment for Apnea Reduction (STAR) trial participants.
  
  
  METHODS
  Prospective multicenter single group trial with participants serving as their own controls.
  
  
  METHODS
  Twenty-two community and academic sleep medicine and otolaryngology practices.
  
  
  METHODS
  Primary outcome measures were the apnea-hypopnea index (AHI) and the 4% oxygen desaturation index (ODI). Secondary outcome measures were the Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), and oxygen saturation percent time < 90% during sleep. Stimulation level for each participant was collected at three predefined thresholds during awake testing. Procedure- and/or device-related adverse events were reviewed and coded by the Clinical Events Committee.
  
  
  RESULTS
  The median AHI was reduced by 67.4% from the baseline of 29.3 to 9.7/h at 18 mo. The median ODI was reduced by 67.5% from 25.4 to 8.6/h at 18 mo. The FOSQ and ESS improved significantly at 18 mo compared to baseline values. The functional threshold was unchanged from baseline at 18 mo. Two participants experienced a serious device-related adverse event requiring neurostimulator repositioning and fixation. No tongue weakness reported at 18 mo.
  
  
  CONCLUSIONS
  Upper airway stimulation via the hypoglossal nerve maintained a durable effect of improving airway stability during sleep and improved patient reported outcomes (Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire) without an increase of the stimulation thresholds or tongue injury at 18 mo of follow-up.
authors.affiliation: Division of Pulmonary Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Strollo
authors.affiliation: Department of Otolaryngology, Medical College of South Carolina Charleston, SC.
authors.forename: M Boyd
authors.initials: MB
authors.lastname: Gillespie
authors.affiliation: Department of Otolaryngology, University of Pittsburgh, Pittsburgh, PA.
authors.forename: Ryan J
authors.initials: RJ
authors.lastname: Soose
authors.affiliation: Department of Otorhinolaryngology, Head & Neck Surgery, Sleep Disorders Center, University Hospital Mannheim, Mannheim, Germany.
authors.forename: Joachim T
authors.initials: JT
authors.lastname: Maurer
authors.affiliation: Department of Otolaryngology,Saint Lucas Hospital, Amsterdam, Netherlands.
authors.forename: Nico
authors.initials: N
authors.lastname: de Vries
authors.affiliation: North Memorial Sleep Health Center, Maple Grove, MN.
authors.forename: Jason
authors.initials: J
authors.lastname: Cornelius
authors.affiliation: St. Cloud Ear, Nose & Throat, St. Cloud, MN.
authors.forename: Ronald D
authors.initials: RD
authors.lastname: Hanson
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, University of South Florida College of Medicine, Tampa, FL.
authors.forename: Tapan A
authors.initials: TA
authors.lastname: Padhya
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, University of Cincinnati Academic Health Center, Cincinnati, OH.
authors.forename: David L
authors.initials: DL
authors.lastname: Steward
authors.affiliation: Department of Otolaryngology and Human Communication, Medical College of Wisconsin, Milwaukee, WI.
authors.forename: B Tucker
authors.initials: BT
authors.lastname: Woodson
authors.affiliation: Department of Pulmonary Medicine, Multidisciplinary Sleep Disorders Center, Antwerp University Hospital, Antwerp, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: Verbraecken
authors.affiliation: Department of Otorhinolaryngology and Head & Neck Surgery, Multidisciplinary Sleep Disorders Center, Antwerp University Hospital, Antwerp, Belgium.
authors.forename: Olivier M
authors.initials: OM
authors.lastname: Vanderveken
authors.affiliation: Sleep Disorders Center, Borgess Medical Center, Kalamazoo, MI.
authors.forename: Mark G
authors.initials: MG
authors.lastname: Goetting
authors.affiliation: St. Petersburg Sleep Disorders Center St. Petersburg, FL.
authors.forename: Neil
authors.initials: N
authors.lastname: Feldman
authors.affiliation: Hôpital Foch, Suresnes, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Chabolle
authors.affiliation: Division of Pulmonary, Critical Care & Sleep Medicine, Wayne State University, Detroit, MI.
authors.forename: M Safwan
authors.initials: MS
authors.lastname: Badr
authors.affiliation: Krankenhaus Bethanien Solingen, Soligen, Germany.
authors.forename: Winfried
authors.initials: W
authors.lastname: Randerath
authors.affiliation: Division of Pulmonary, Critical Care & Sleep Medicine, Case Western Reserve University, Cleveland, OH.
authors.forename: Kingman P
authors.initials: KP
authors.lastname: Strohl
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007002:Hypoglossal Nerve / Q000502:physiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012137:Respiratory System; D012890:Sleep / Q000502:physiology; D012891:Sleep Apnea Syndromes / Q000503:physiopathology / Q000628:therapy; D020181:Sleep Apnea, Obstructive / Q000503:physiopathology* / Q000628:therapy*; D011795:Surveys and Questionnaires; D013997:Time Factors; D014059:Tongue / Q000502:physiology; D014851:Wakefulness
keywords: hypoglossal nerve stimulation; obstructive sleep apnea; pacing; therapy; upper airway stimulation