Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/21888
Title: Bilateral Hypoglossal Nerve Stimulation for Treatment of Adult Obstructive Sleep Apnea.
Authors: Eastwood, Peter R;Barnes, Maree;MacKay, Stuart G;Wheatley, John R;Hillman, David R;Nguyên, Xuân-Lan;Lewis, Richard;Campbell, Matthew C;Pételle, Boris;Walsh, Jennifer H;Jones, Andrew C;Palme, Carsten E;Bizon, Alain;Meslier, Nicole;Bertolus, Chloé;Maddison, Kathleen J;Laccourreye, Laurent;Raux, Guillaume;Denoncin, Katleen;Attali, Valérie;Gagnadoux, Frédéric;Launois, Sandrine H
Affiliation: The Department of Otolaryngology Head Neck Surgery, Westmead Hospital, Westmead, NSW, Australia
University of Sydney at Westmead Hospital, Westmead, NSW, Australia
Ludwig Engel Centre for Respiratory Research, The Westmead Institute for Medical Research, Westmead, NSW, Australia
Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Western Australia, Australia
West Australian Sleep Disorders Research Institute, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
Dept. Otolaryngology, Head & Neck Surgery, Royal Perth Hospital, Perth, Western Australia, Australia
Hollywood Private Hospital, Perth, Western Australia, Australia
Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Western Australia, Australia. West Australian Sleep Disorders Research Institute, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
Unité de Somnologie et Fonction Respiratoire, Hopital St Antoine, Paris, France
Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France
Department of Respiratory and Sleep Medicine, University Hospital of Angers, Angers, France
INSERM UMR 1063 "SOPAM", University of Angers, Angers, France
Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France
AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service des Pathologies du Sommeil (Département "R3S"), Paris, France
AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Stomatologie et Chirurgie Maxillo-faciale, Paris, France
Institute for Breathing and Sleep, Austin Health, Heidelberg, Victoria, Australia
University of Melbourne, Parkville, Victoria, Australia
Illawarra ENT Head & Neck Clinic, Wollongong, NSW, Australia
Wollongong Hospital, Illawarra Shoalhaven Local Health District (ISLHD), Wollongong, NSW, Australia
Graduate School of Medicine, University of Wollongong, Wollongong, NSW, Australia
Woolcock Institute of Medical Research, Glebe, NSW, Australia
Department of Respiratory and Sleep Medicine, Westmead Hospital, Westmead, NSW, Australia
Service ORL Chirurgie de la Face et du Cou, Hôpital Tenon, AP-HP, Paris, Sorbonne Université, Paris, France
Dept. Otolaryngology, Head &Neck surgery, University Hospital of Angers, France
Nyxoah, S.A., Mont-Saint-Guibert, Belgium
Issue Date: 10-Oct-2019
EDate: 2019-10-10
Citation: The European respiratory journal 2019; online first: 10 October
Abstract: Hypoglossal Nerve Stimulation (HNS) decreases Obstructive Sleep Apnea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system. This prospective, open-label, non-randomised, single arm treatment study was conducted at eight centres in three countries (Australia, France, UK). Primary outcomes were incidence of device-related Serious Adverse Events (SAEs) and change in the Apnea-Hypopnea Index (AHI). The secondary outcome was the change in the 4% Oxygen Desaturation Index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring, and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604. From 27 implanted participants (63% male, aged 55.9±12.0 years, BMI 27.4±3.0 kg·m-2), 22 completed the protocol. At 6 months BMI was unchanged (p=0.85), AHI decreased from 23.7±12.2 to 12.9±10.1 events·hr-1, a mean change of 10.8 events·hr-1 (p<0.001); ODI decreased from 19.1±11.2 to 9.8±6.9 events·hr-1, a mean change of 9.3 events·hr-1 (p<0.001). Daytime sleepiness (ESS, p=0.01) and sleep-related quality of life (FOSQ-10, p=0.02) both significantly improved. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. Ninety-one percent of participants reported device use >5 days per week, and 77% reported use for >5 hrs per night. No device-related SAE occurred during the 6-months post-implantation period. Bilateral HNS using the Genio™ system reduces OSA severity and improve quality of life without device related complication. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.
URI: http://ahro.austin.org.au/austinjspui/handle/1/21888
DOI: 10.1183/13993003.01320-2019
ORCID: 0000-0002-4490-4138
PubMed URL: 31601716
Type: Journal Article
Appears in Collections:Journal articles

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