Treating obstructive sleep apnea with hypoglossal nerve stimulation

Peter R Eastwood; Maree Barnes; Jennifer H Walsh; Kathleen J Maddison; Geoffrey Hee; Alan R Schwartz; Philip L Smith; Atul Malhotra; R Douglas McEvoy; John R Wheatley; Fergal J O'Donoghue; Peter D Rochford; Tom Churchward; Matthew C Campbell; Carsten E Palme; Sam Robinson; George S Goding; Danny J Eckert; Amy S Jordan; Peter G Catcheside; Louise Tyler; Nick A Antic; Christopher J Worsnop; Eric J Kezirian; David R Hillman

doi:10.5665/sleep.1380

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Treating obstructive sleep apnea with hypoglossal nerve stimulation

Journal article

Peer reviewed

Treating obstructive sleep apnea with hypoglossal nerve stimulation

Peter R Eastwood, Maree Barnes, Jennifer H Walsh, Kathleen J Maddison, Geoffrey Hee, Alan R Schwartz, Philip L Smith, Atul Malhotra, R Douglas McEvoy, John R Wheatley, …

Sleep (New York, N.Y.), Vol.34(11), pp.1479-1486

2011

DOI: https://doi.org/10.5665/sleep.1380

PMCID: PMC3198202

PMID: 22043118

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Abstract

sleep apnea

hypoglossal nerve stimulation

implantable neurostimulator

genioglossus muscle

lung

Background: Reduced upper airway muscle activity during sleep is fundamental to obstructive sleep apnea (OSA) pathogenesis. Hypoglossal nerve stimulation (HGNS) counteracts this problem, with potential to reduce OSA severity. Study Objectives: To examine safety and efficacy of a novel HGNS system (HGNS, Apnex Medical, Inc.) in treating OSA. Participants: Twenty-one patients, 67% male, age (mean ± SD) 53.6 ± 9.2 years, with moderate to severe OSA and unable to tolerate continuous positive airway pressure (CPAP). Design: Each participant underwent surgical implantation of the HGNS system in a prospective single-arm interventional trial. OSA severity was defined by apnea-hypopnea index (AHI) during in-laboratory polysomnography (PSG) at baseline and 3 and 6 months post-implant. Therapy compliance was assessed by nightly hours of use. Symptoms were assessed using the Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Calgary Sleep Apnea Quality of Life Index (SAQLI), and the Beck Depression Inventory (BDI). Results: HGNS was used on 89% ± 15% of nights (n = 21). On these nights, it was used for 5.8 ± 1.6 h per night. Nineteen of 21 participants had baseline and 6-month PSGs. There was a significant improvement (all P < 0.05) from baseline to 6 months in: AHI (43.1 ± 17.5 to 19.5 ± 16.7), ESS (12.1 ± 4.7 to 8.1 ± 4.4), FOSQ (14.4 ± 2.0 to 16.7 ± 2.2), SAQLI (3.2 ± 1.0 to 4.9 ± 1.3), and BDI (15.8 ± 9.0 to 9.7 ± 7.6). Two serious device-related adverse events occurred: an infection requiring device removal and a stimulation lead cuff dislodgement requiring replacement. Conclusions: HGNS demonstrated favorable safety, efficacy, and compliance. Participants experienced a significant decrease in OSA severity and OSA-associated symptoms.

Details

Title: Treating obstructive sleep apnea with hypoglossal nerve stimulation
Authors/Creators: Peter R Eastwood - Sir Charles Gairdner Hospital
Maree Barnes - Austin Health
Jennifer H Walsh - Sir Charles Gairdner Hospital
Kathleen J Maddison - Sir Charles Gairdner Hospital
Geoffrey Hee
Alan R Schwartz - Johns Hopkins School of Medicine; Baltimore MD
Philip L Smith - Johns Hopkins School of Medicine; Baltimore MD
Atul Malhotra - Harvard University
R Douglas McEvoy
John R Wheatley - Westmead Hospital
Fergal J O'Donoghue - The University of Melbourne
Peter D Rochford - Austin Health
Tom Churchward
Matthew C Campbell - Institute for Breathing and Sleep
Carsten E Palme - Westmead Hospital
Sam Robinson - Flinders University
George S Goding - University of Minnesota
Danny J Eckert - Brigham and Women's Hospital
Amy S Jordan - The University of Melbourne
Peter G Catcheside - Flinders University
Louise Tyler - Westmead Hospital
Nick A Antic - Flinders University
Christopher J Worsnop - Institute for Breathing and Sleep
Eric J Kezirian - University of California, San Francisco
David R Hillman - Sir Charles Gairdner Hospital
Publication Details: Sleep (New York, N.Y.), Vol.34(11), pp.1479-1486
Grant note: P01 HL095491 / NHLBI NIH HHS K24 HL093218 / NHLBI NIH HHS R01 HL085188 / NHLBI NIH HHS R01 HL090897 / NHLBI NIH HHS
Identifiers: 991005591573707891
Murdoch Affiliation: Vice Chancellery
Language: English
Resource Type: Journal article

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Collaboration types: Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.137 Sleep Science & Circadian Systems; 1.137.382 Obstructive Sleep Apnea
Web Of Science research areas: Clinical Neurology; Neurosciences
ESI research areas: Neuroscience & Behavior