Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes

Eric J. Kezirian, George S. Goding, Atul Malhotra, Fergal J. O'Donoghue, Gary Zammit, John R. Wheatley, Peter G. Catcheside, Philip L. Smith, Alan R. Schwartz, Jennifer H. Walsh, Kathleen J. Maddison, David M. Claman, Tod Huntley, Steven Y. Park, Matthew C. Campbell, Carsten E. Palme, Conrad Iber, Peter R. Eastwood, David R. Hillman, Maree Barnes

Research output: Contribution to journalArticle

58 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)77-83
Number of pages7
JournalJournal of Sleep Research
Volume23
Issue number1
DOIs
StatePublished - Feb 2014

Fingerprint

Hypoglossal Nerve
Obstructive Sleep Apnea
Sleep
Apnea
Device Removal
Safety
Muscles
Quality of Life
Pressure
Equipment and Supplies
Infection

Keywords

  • Hypoglossal nerve
  • Neurostimulation
  • Sleep apnea
  • Surgery

ASJC Scopus subject areas

  • Behavioral Neuroscience
  • Cognitive Neuroscience
  • Medicine(all)

Cite this

Kezirian, E. J., Goding, G. S., Malhotra, A., O'Donoghue, F. J., Zammit, G., Wheatley, J. R., ... Barnes, M. (2014). Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. Journal of Sleep Research, 23(1), 77-83. https://doi.org/10.1111/jsr.12079

Hypoglossal nerve stimulation improves obstructive sleep apnea : 12-month outcomes. / Kezirian, Eric J.; Goding, George S.; Malhotra, Atul; O'Donoghue, Fergal J.; Zammit, Gary; Wheatley, John R.; Catcheside, Peter G.; Smith, Philip L.; Schwartz, Alan R.; Walsh, Jennifer H.; Maddison, Kathleen J.; Claman, David M.; Huntley, Tod; Park, Steven Y.; Campbell, Matthew C.; Palme, Carsten E.; Iber, Conrad; Eastwood, Peter R.; Hillman, David R.; Barnes, Maree.

In: Journal of Sleep Research, Vol. 23, No. 1, 02.2014, p. 77-83.

Research output: Contribution to journalArticle

Kezirian, EJ, Goding, GS, Malhotra, A, O'Donoghue, FJ, Zammit, G, Wheatley, JR, Catcheside, PG, Smith, PL, Schwartz, AR, Walsh, JH, Maddison, KJ, Claman, DM, Huntley, T, Park, SY, Campbell, MC, Palme, CE, Iber, C, Eastwood, PR, Hillman, DR & Barnes, M 2014, 'Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes', Journal of Sleep Research, vol. 23, no. 1, pp. 77-83. https://doi.org/10.1111/jsr.12079
Kezirian EJ, Goding GS, Malhotra A, O'Donoghue FJ, Zammit G, Wheatley JR et al. Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. Journal of Sleep Research. 2014 Feb;23(1):77-83. https://doi.org/10.1111/jsr.12079
Kezirian, Eric J. ; Goding, George S. ; Malhotra, Atul ; O'Donoghue, Fergal J. ; Zammit, Gary ; Wheatley, John R. ; Catcheside, Peter G. ; Smith, Philip L. ; Schwartz, Alan R. ; Walsh, Jennifer H. ; Maddison, Kathleen J. ; Claman, David M. ; Huntley, Tod ; Park, Steven Y. ; Campbell, Matthew C. ; Palme, Carsten E. ; Iber, Conrad ; Eastwood, Peter R. ; Hillman, David R. ; Barnes, Maree. / Hypoglossal nerve stimulation improves obstructive sleep apnea : 12-month outcomes. In: Journal of Sleep Research. 2014 ; Vol. 23, No. 1. pp. 77-83.
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