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

doi:10.1111/jsr.12079

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

Otorhinolaryngology - Head & Neck Surgery

Research output: Contribution to journal › Article › peer-review

108 Scopus citations

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 language	English (US)
Pages (from-to)	77-83
Number of pages	7
Journal	Journal of Sleep Research
Volume	23
Issue number	1
DOIs	https://doi.org/10.1111/jsr.12079
State	Published - Feb 2014

Keywords

Hypoglossal nerve
Neurostimulation
Sleep apnea
Surgery

ASJC Scopus subject areas

Cognitive Neuroscience
Behavioral Neuroscience

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10.1111/jsr.12079

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Kezirian, E. J., Goding, G. S., Malhotra, A., O'Donoghue, F. J., Zammit, G., Wheatley, J. R., Catcheside, P. G., Smith, P. L., Schwartz, A. R., Walsh, J. H., Maddison, K. J., Claman, D. M., Huntley, T., Park, S. Y., Campbell, M. C., Palme, C. E., Iber, C., Eastwood, P. R., Hillman, D. 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

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

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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{\textregistered}; 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.",

keywords = "Hypoglossal nerve, Neurostimulation, Sleep apnea, Surgery",

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

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doi = "10.1111/jsr.12079",

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pages = "77--83",

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AU - Kezirian, Eric J.

AU - Goding, George S.

AU - Malhotra, Atul

AU - O'Donoghue, Fergal J.

AU - Zammit, Gary

AU - Wheatley, John R.

AU - Catcheside, Peter G.

AU - Smith, Philip L.

AU - Schwartz, Alan R.

AU - Walsh, Jennifer H.

AU - Maddison, Kathleen J.

AU - Claman, David M.

AU - Huntley, Tod

AU - Park, Steven Y.

AU - Campbell, Matthew C.

AU - Palme, Carsten E.

AU - Iber, Conrad

AU - Eastwood, Peter R.

AU - Hillman, David R.

AU - Barnes, Maree

PY - 2014/2

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N2 - 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.

AB - 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.

KW - Hypoglossal nerve

KW - Neurostimulation

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

Abstract

Keywords

ASJC Scopus subject areas

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