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Clinical Trial
. 2014 Feb;23(1):77-83.
doi: 10.1111/jsr.12079. Epub 2013 Sep 4.

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

Eric J Kezirian  1 , George S Goding Jr, 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
Affiliations
Clinical Trial

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

Eric J Kezirian et al. J Sleep Res. 2014 Feb.

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.

Keywords: hypoglossal nerve; neurostimulation; sleep apnea; surgery.

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Conflict of interest statement

Conflicts of interest

EJK: Apnex Medical (Medical Advisory Board, consultant); ReVENT Medical (Medical Advisory Board); ArthroCare (consultant); Medtronic (consultant); Pavad Medical (consultant). GSG: Apnex Medical (consultant). AM: has consulting/research income from Philips, Apnex, Apnicure, Pfizer, SHC, and SGS but has relinquished all outside personal income since May 2012. GZ: grants/research support (Abbott, Actelion, Ancile, Apnex, Arena, Astra-Zeneca, Aventis, Banyu, Biomarin, BMS, Catalyst, Cephalon Inc., CHDI, Elan, Epix, Eisal, Elminda, Evotec, Forest, Galderma, GlaxoSmithKline, Gilead, H. Lundbeck A/s, King, Merck and Co., National Institutes of Health, Neurim, Neurocrine Biosciences, Naurex, Neurogen, Novo Nordisk, Organon, Orphan Medical, Otsuka, Pfizer, Predix, Respironics, Saladax, Sanofi-Aventis, Sanofi-Synthelabo, Schering-Plough, Sepracor, Shire, Somaxon, Takeda Pharmaceuticals North America, Targacept, Teva, Thymon, Transcept, UCB Pharma, Ultragenyx, Predix, Venda, Wyeth-Ayerst Research; consultant: Acorda, Actelion, Alexza, Arena, Aventis, Biovail, Boehringer-Ingelheim, Cephalon, Elan, Eli Lilly, Evotec, Forest, GlaxoSmithKline, Jazz, King Pharmaceuticals, Ligand, McNeil, Merck, Neurocrine Biosciences, Organon, Pfizer, Purdue, Renovis, Sanofi-Aventis, Select Comfort, Sepracor, Shire, Somnus, Takeda Pharmaceuticals, Vela, Wyeth; honoraria: Neurocrine Biosciences, King Pharmaceuticals, McNeil, Sanofi-Aventis, Sanofi-Synthelabo, Sepracor, Takeda Pha rmaceuticals, Vela Pharmaceuticals, Wyeth-Ayerst Research; ownership, directorship: Clinilabs Inc., Clinilabs IPA, Clinilabs Physician Services. PLS: Apnex Medical (Medical Advisory Board). ARS: Apnex Medical (Scientific Advisory Board). TH: Apnex Medical (Medical Advisory Board, compensated surgical proctor). SYP: Apnex Medical (compensated surgical proctor). CEP: Apnex Medical (consultant). CI: Apnex Medical (salary support). PRE: Apnex Medical (Medical Advisory Board, consultant). DRH: Apnex Medical (Medical Advisory Board). MB: Fisher & Paykel (attendance at Clinical Research Forum), Bird Pty Ltd (salary support for research assistant for investigator driven research project), ResMed (provision of equipment for investigator driven research project),sponsored clinical trials with no direct monies received (Actelion, Boehringer-Ingelheim, Apnex Medical, GlaxoSmithKline, Novartis, Hunter Immunology, Pearl Therapeutics, Sanofi-Aventis).

Figures

Figure 1
Figure 1
The implanted components of the hypoglossal nerve stimulating system include a neurostimulator that delivers safe levels of electrical stimulation to one hypoglossal nerve via a stimulation lead having a distal cuff electrode. Respiration sensing leads detect inspiration using bioimpedance, so that the system delivers stimulation synchronous with inspiration.
Figure 2
Figure 2
Box and whisker plot of the apnoea-hypopnoea index at baseline and at 6 and 12 months post implantation. The median values are noted by horizontal white lines, and the boxes represent the intraquartile range. The whiskers represent the 1.5x the intraquartile range (or the minimum or maximum value if < 1.5x the intraquartile range). The Xs represent outlier values.
Figure 3
Figure 3
Box and whisker plot of the apnea-hypopnea index at baseline and at 3, 6, and 12 months post implantation, shown separately for BMI ≤ 35 kg/m2 and BMI > 35 kg/m2. The median values are noted by horizontal white lines, and the boxes represent the intraquartile range. The whiskers represent the 1.5x the intraquartile range (or the minimum or maximum value if < 1.5x the intraquartile range). The Xs represent outlier values.
See this image and copyright information in PMC

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