title: Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes.
abstract: Reduced upper airway muscle activity during sleep is a key contributor to obstructive sleep apnea pathogenesis. Hypoglossal nerve stimulation activates upper airway dilator muscles, including the genioglossus, and has the potential to reduce obstructive sleep apnea severity. The objective of this study was to examine the safety, feasibility and efficacy of a novel hypoglossal nerve stimulation system (HGNS; Apnex Medical, St Paul, MN, USA) in treating obstructive sleep apnea at 12 months following implantation. Thirty-one subjects (35% female, age 52.4 ± 9.4 years) with moderate to severe obstructive sleep apnea and unable to tolerate positive airway pressure underwent surgical implantation and activation of the hypoglossal nerve stimulation system in a prospective single-arm interventional trial. Primary outcomes were changes in obstructive sleep apnea severity (apnea-hypopnea index, from in-laboratory polysomnogram) and sleep-related quality of life [Functional Outcomes of Sleep Questionnaire (FOSQ)]. Hypoglossal nerve stimulation was used on 86 ± 16% of nights for 5.4 ± 1.4 h per night. There was a significant improvement (P < 0.001) from baseline to 12 months in apnea-hypopnea index (45.4 ± 17.5 to 25.3 ± 20.6 events h(-1) ) and Functional Outcomes of Sleep Questionnaire score (14.2 ± 2.0 to 17.0 ± 2.4), as well as other polysomnogram and symptom measures. Outcomes were stable compared with 6 months following implantation. Three serious device-related adverse events occurred: an infection requiring device removal; and two stimulation lead cuff dislodgements requiring replacement. There were no significant adverse events with onset later than 6 months following implantation. Hypoglossal nerve stimulation demonstrated favourable safety, feasibility and efficacy.
authors.affiliation: Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Kezirian
authors.forename: George S
authors.initials: GS
authors.lastname: Goding
authors.forename: Atul
authors.initials: A
authors.lastname: Malhotra
authors.forename: Fergal J
authors.initials: FJ
authors.lastname: O'Donoghue
authors.forename: Gary
authors.initials: G
authors.lastname: Zammit
authors.forename: John R
authors.initials: JR
authors.lastname: Wheatley
authors.forename: Peter G
authors.initials: PG
authors.lastname: Catcheside
authors.forename: Philip L
authors.initials: PL
authors.lastname: Smith
authors.forename: Alan R
authors.initials: AR
authors.lastname: Schwartz
authors.forename: Jennifer H
authors.initials: JH
authors.lastname: Walsh
authors.forename: Kathleen J
authors.initials: KJ
authors.lastname: Maddison
authors.forename: David M
authors.initials: DM
authors.lastname: Claman
authors.forename: Tod
authors.initials: T
authors.lastname: Huntley
authors.forename: Steven Y
authors.initials: SY
authors.lastname: Park
authors.forename: Matthew C
authors.initials: MC
authors.lastname: Campbell
authors.forename: Carsten E
authors.initials: CE
authors.lastname: Palme
authors.forename: Conrad
authors.initials: C
authors.lastname: Iber
authors.forename: Peter R
authors.initials: PR
authors.lastname: Eastwood
authors.forename: David R
authors.initials: DR
authors.lastname: Hillman
authors.forename: Maree
authors.initials: M
authors.lastname: Barnes
mesh_terms: D000328:Adult; D000368:Aged; D001315:Australia; D005260:Female; D006801:Humans; D007002:Hypoglossal Nerve / Q000502:physiology*; D058542:Implantable Neurostimulators / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D017286:Polysomnography; D011788:Quality of Life; D012890:Sleep / Q000502:physiology*; D020181:Sleep Apnea, Obstructive / Q000503:physiopathology* / Q000601:surgery*; D011795:Surveys and Questionnaires; D013997:Time Factors; D014481:United States; D055815:Young Adult
keywords: hypoglossal nerve; neurostimulation; sleep apnea; surgery
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