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

被引：107

作者：

Kezirian, Eric J. ^{[1
]}

Goding, George S., Jr. ^{[2
]}

Malhotra, Atul ^{[3
]}

O'Donoghue, Fergal J. ^{[4
,5
]}

Zammit, Gary ^{[6
]}

Wheatley, John R. ^{[7
]}

Catcheside, Peter G. ^{[8
,9
,10
]}

Smith, Philip L. ^{[11
]}

Schwartz, Alan R. ^{[11
]}

Walsh, Jennifer H. ^{[12
,13
]}

Maddison, Kathleen J. ^{[12
,13
]}

Claman, David M. ^{[14
]}

Huntley, Tod ^{[15
]}

Park, Steven Y. ^{[16
]}

Campbell, Matthew C. ^{[4
]}

Palme, Carsten E. ^{[7
]}

Iber, Conrad ^{[2
]}

Eastwood, Peter R. ^{[12
,13
]}

Hillman, David R. ^{[12
,13
]}

Barnes, Maree ^{[4
,5
]}

机构：

[1] Univ So Calif, Keck Sch Med, Los Angeles, CA 90033 USA

[2] Univ Minnesota, Minneapolis, MN USA

[3] Univ Calif San Diego, San Diego, CA 92103 USA

[4] Austin Hlth, Inst Breathing & Sleep, Melbourne, Vic, Australia

[5] Univ Melbourne, Melbourne, Vic, Australia

[6] Clinilabs Inc, New York, NY USA

[7] Westmead Hosp, Sydney, NSW, Australia

[8] Repatriat Gen Hosp, Adelaide, SA, Australia

[9] Flinders Univ S Australia, Adelaide, SA 5001, Australia

[10] Adelaide Inst Sleep Heath, Adelaide, SA, Australia

[11] Johns Hopkins Sch Med, Baltimore, MD USA

[12] Sir Charles Gairdner Hosp, Perth, WA, Australia

[13] Univ Western Australia, Perth, WA 6009, Australia

[14] Univ Calif San Francisco, San Francisco, CA 94143 USA

[15] St Vincent Hosp, Ctr Ear Nose Throat & Allergy, Indianapolis, IN USA

[16] Montefiore Med Ctr, Albert Einstein Coll Med, Bronx, NY 10467 USA

来源：

JOURNAL OF SLEEP RESEARCH | 2014年 / 23卷 / 01期

基金：

澳大利亚国家健康与医学研究理事会; 美国国家卫生研究院; 英国医学研究理事会;

关键词：

hypoglossal nerve; neurostimulation; sleep apnea; surgery; UPPER AIRWAY; BREATHING DISORDERS; ADULTS; INSTRUMENT; INDEX;

D O I：

10.1111/jsr.12079

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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((R)); Apnex Medical, St Paul, MN, USA) in treating obstructive sleep apnea at 12months following implantation. Thirty-one subjects (35% female, age 52.4 +/- 9.4years) 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 +/- 1.4h per night. There was a significant improvement (P<0.001) from baseline to 12months in apnea-hypopnea index (45.4 +/- 17.5 to 25.3 +/- 20.6eventsh(-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 6months 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 6months following implantation. Hypoglossal nerve stimulation demonstrated favourable safety, feasibility and efficacy.

引用

页码：77 / 83

页数：7

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