title: Implanted upper airway stimulation device for obstructive sleep apnea.
abstract: OBJECTIVE
  Previous feasibility studies have shown that electrical stimulation of the hypoglossal nerve can improve obstructive sleep apnea (OSA). The current study examined the safety and preliminary effectiveness of a second generation device, the Upper Airway Stimulation (UAS) system, and identified baseline predictors for therapy success.
  
  
  METHODS
  Two consecutive open prospective studies.
  
  
  METHODS
  UAS systems were implanted in patients with moderate to severe OSA who failed or were intolerant of continuous positive airway pressure (CPAP). The study was conducted in 2 parts. In part 1, patients were enrolled with broad selection criteria. Apnea hypopnea index (AHI) was collected using laboratory-based polysomnography at preimplant and postimplant visits. Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ) were also collected. In part 2, patients were enrolled using selection criteria derived from the experience in part 1.
  
  
  RESULTS
  In part 1, 20 of 22 enrolled patients (two exited the study) were examined for factors predictive of therapy response. Responders had both a body mass index ≤32 and AHI ≤50 (P < .05) and did not have complete concentric palatal collapse. Part 2 patients (n = 8) were selected using responder criteria and showed an improvement on AHI from baseline, from 38.9 ± 9.8 to 10.0 ± 11.0 (P < .01) at 6 months postimplant. Both ESS and FOSQ improved significantly in part 1 and 2 subjects.
  
  
  CONCLUSIONS
  The current study has demonstrated that therapy with upper airway stimulation is safe and efficacious in a select group of patients with moderate to severe OSA who cannot or will not use CPAP as primary treatment.
authors.affiliation: Department of Otorhinolaryngology and Head & Neck Surgery, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium. paul.van.de.heyning@telenet.be
authors.forename: Paul H
authors.initials: PH
authors.lastname: Van de Heyning
authors.forename: M Safwan
authors.initials: MS
authors.lastname: Badr
authors.forename: Jonathan Z
authors.initials: JZ
authors.lastname: Baskin
authors.forename: Michel A
authors.initials: MA
authors.lastname: Cramer Bornemann
authors.forename: Wilfried A
authors.initials: WA
authors.lastname: De Backer
authors.forename: Yaniv
authors.initials: Y
authors.lastname: Dotan
authors.forename: Winfried
authors.initials: W
authors.lastname: Hohenhorst
authors.forename: Lennart
authors.initials: L
authors.lastname: Knaack
authors.forename: Ho-Sheng
authors.initials: HS
authors.lastname: Lin
authors.forename: Joachim T
authors.initials: JT
authors.lastname: Maurer
authors.forename: Aviram
authors.initials: A
authors.lastname: Netzer
authors.forename: Rick M
authors.initials: RM
authors.lastname: Odland
authors.forename: Arie
authors.initials: A
authors.lastname: Oliven
authors.forename: Kingman P
authors.initials: KP
authors.lastname: Strohl
authors.forename: Olivier M
authors.initials: OM
authors.lastname: Vanderveken
authors.forename: Johan
authors.initials: J
authors.lastname: Verbraecken
authors.forename: B Tucker
authors.initials: BT
authors.lastname: Woodson
mesh_terms: D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D058542:Implantable Neurostimulators; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020181:Sleep Apnea, Obstructive / Q000628:therapy*