title: Treating obstructive sleep apnea with hypoglossal nerve stimulation.
abstract: BACKGROUND
  Reduced upper airway muscle activity during sleep is fundamental to obstructive sleep apnea (OSA) pathogenesis. Hypoglossal nerve stimulation (HGNS) counteracts this problem, with potential to reduce OSA severity.
  
  
  OBJECTIVE
  To examine safety and efficacy of a novel HGNS system (HGNS, Apnex Medical, Inc.) in treating OSA.
  
  
  METHODS
  Twenty-one patients, 67% male, age (mean ± SD) 53.6 ± 9.2 years, with moderate to severe OSA and unable to tolerate continuous positive airway pressure (CPAP).
  
  
  METHODS
  Each participant underwent surgical implantation of the HGNS system in a prospective single-arm interventional trial. OSA severity was defined by apnea-hypopnea index (AHI) during in-laboratory polysomnography (PSG) at baseline and 3 and 6 months post-implant. Therapy compliance was assessed by nightly hours of use. Symptoms were assessed using the Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Calgary Sleep Apnea Quality of Life Index (SAQLI), and the Beck Depression Inventory (BDI).
  
  
  RESULTS
  HGNS was used on 89% ± 15% of nights (n = 21). On these nights, it was used for 5.8 ± 1.6 h per night. Nineteen of 21 participants had baseline and 6-month PSGs. There was a significant improvement (all P < 0.05) from baseline to 6 months in: AHI (43.1 ± 17.5 to 19.5 ± 16.7), ESS (12.1 ± 4.7 to 8.1 ± 4.4), FOSQ (14.4 ± 2.0 to 16.7 ± 2.2), SAQLI (3.2 ± 1.0 to 4.9 ± 1.3), and BDI (15.8 ± 9.0 to 9.7 ± 7.6). Two serious device-related adverse events occurred: an infection requiring device removal and a stimulation lead cuff dislodgement requiring replacement.
  
  
  CONCLUSIONS
  HGNS demonstrated favorable safety, efficacy, and compliance. Participants experienced a significant decrease in OSA severity and OSA-associated symptoms.
  
  
  BACKGROUND
  NAME: Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea.
  
  
  BACKGROUND
  NCT01186926. URL: http://clinicaltrials.gov/ct2/show/NCT01186926.
authors: Sir Charles Gairdner Hospital, Perth, Australia. Peter.Eastwood@health.wa.gov.au
authors: Peter R
authors: PR
authors: Eastwood
authors: Maree
authors: M
authors: Barnes
authors: Jennifer H
authors: JH
authors: Walsh
authors: Kathleen J
authors: KJ
authors: Maddison
authors: Geoffrey
authors: G
authors: Hee
authors: Alan R
authors: AR
authors: Schwartz
authors: Philip L
authors: PL
authors: Smith
authors: Atul
authors: A
authors: Malhotra
authors: R Douglas
authors: RD
authors: McEvoy
authors: John R
authors: JR
authors: Wheatley
authors: Fergal J
authors: FJ
authors: O'Donoghue
authors: Peter D
authors: PD
authors: Rochford
authors: Tom
authors: T
authors: Churchward
authors: Matthew C
authors: MC
authors: Campbell
authors: Carsten E
authors: CE
authors: Palme
authors: Sam
authors: S
authors: Robinson
authors: George S
authors: GS
authors: Goding
authors: Danny J
authors: DJ
authors: Eckert
authors: Amy S
authors: AS
authors: Jordan
authors: Peter G
authors: PG
authors: Catcheside
authors: Louise
authors: L
authors: Tyler
authors: Nick A
authors: NA
authors: Antic
authors: Christopher J
authors: CJ
authors: Worsnop
authors: Eric J
authors: EJ
authors: Kezirian
authors: David R
authors: DR
authors: Hillman
mesh_terms: D000328:Adult; D000368:Aged; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D007002:Hypoglossal Nerve / Q000502:physiology; D058542:Implantable Neurostimulators; D008297:Male; D008875:Middle Aged; D017286:Polysomnography; D011788:Quality of Life; D020181:Sleep Apnea, Obstructive / Q000503:physiopathology / Q000628:therapy*; D016896:Treatment Outcome