title: Randomized controlled withdrawal study of upper airway stimulation on OSA: short- and long-term effect.
abstract: OBJECTIVE
  To assess the efficacy and durability of upper airway stimulation via the hypoglossal nerve on obstructive sleep apnea (OSA) severity including objective and subjective clinical outcome measures.
  
  
  METHODS
  A randomized controlled therapy withdrawal study.
  
  
  METHODS
  Industry-supported multicenter academic and clinical setting.
  
  
  METHODS
  A consecutive cohort of 46 responders at 12 months from a prospective phase III trial of 126 implanted participants.
  
  
  METHODS
  Participants were randomized to either therapy maintenance ("ON") group or therapy withdrawal ("OFF") group for a minimum of 1 week. Short-term withdrawal effect as well as durability at 18 months of primary (apnea hypopnea index and oxygen desaturation index) and secondary outcomes (arousal index, oxygen desaturation metrics, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, snoring, and blood pressure) were assessed.
  
  
  RESULTS
  Both therapy withdrawal group and maintenance group demonstrated significant improvements in outcomes at 12 months compared to study baseline. In the randomized assessment, therapy withdrawal group returned to baseline, and therapy maintenance group demonstrated no change. At 18 months with therapy on in both groups, all objective respiratory and subjective outcome measures showed sustained improvement similar to those observed at 12 months.
  
  
  CONCLUSIONS
  Withdrawal of therapeutic upper airway stimulation results in worsening of both objective and subjective measures of sleep and breathing, which when resumed results in sustained effect at 18 months. Reduction of obstructive sleep apnea severity and improvement of quality of life were attributed directly to the effects of the electrical stimulation of the hypoglossal nerve.
authors.affiliation: Medical College Wisconsin, Milwaukee, Wisconsin, USA bwoodson@mcw.edu.
authors.forename: B Tucker
authors.initials: BT
authors.lastname: Woodson
authors.affiliation: Medical University of South Carolina, Charleston, South Carolina, USA.
authors.forename: M Boyd
authors.initials: MB
authors.lastname: Gillespie
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
authors.forename: Ryan J
authors.initials: RJ
authors.lastname: Soose
authors.affiliation: University Hospital Mannheim, Mannheim, Germany.
authors.forename: Joachim T
authors.initials: JT
authors.lastname: Maurer
authors.affiliation: Saint Lucas Andreas Hospital, Amsterdam, Netherland.
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: University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: Tapan A
authors.initials: TA
authors.lastname: Padhya
authors.affiliation: Wayne State University, Detroit, Michigan, USA.
authors.forename: Ho-sheng
authors.initials: HS
authors.lastname: Lin
authors.affiliation: Advanced ENT, Atlanta, Georgia, USA.
authors.forename: Sam
authors.initials: S
authors.lastname: Mickelson
authors.affiliation: Wayne State University, Detroit, Michigan, USA.
authors.forename: Safwan M
authors.initials: SM
authors.lastname: Badr
authors.affiliation: Case Western Reserve University, Cleveland, Ohio, USA.
authors.forename: Kingman P
authors.initials: KP
authors.lastname: Strohl
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Strollo
mesh_terms: D004599:Electric Stimulation Therapy / Q000379:methods; D005260:Female; D006801:Humans; D007002:Hypoglossal Nerve; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D028761:Withholding Treatment
keywords: OSA; hypoglossal nerve; obstructive sleep apnea; randomized controlled trial; sleep; sleep apnea; surgery; treatment; upper airway stimulation