Please use this identifier to cite or link to this item:
https://ahro.austin.org.au/austinjspui/handle/1/21888| Title: | Bilateral Hypoglossal Nerve Stimulation for Treatment of Adult Obstructive Sleep Apnea. | Austin 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 West Australian Sleep Disorders Research Institute, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Western Australia, 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 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: | 9-Jan-2020 | Date: | 2019-10-10 | Publication information: | The European respiratory journal 2020 55(1): 1901320 | 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: | https://ahro.austin.org.au/austinjspui/handle/1/21888 | DOI: | 10.1183/13993003.01320-2019 | ORCID: | 0000-0002-4490-4138 | Journal: | The European respiratory journal | PubMed URL: | 31601716 | Type: | Journal Article |
| Appears in Collections: | Journal articles |
Show full item record
Items in AHRO are protected by copyright, with all rights reserved, unless otherwise indicated.