{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T08:18:14Z","timestamp":1790410694124,"version":"4.1.0"},"reference-count":42,"publisher":"European Respiratory Society (ERS)","issue":"1","license":[{"start":{"date-parts":[[2019,10,10]],"date-time":"2019-10-10T00:00:00Z","timestamp":1570665600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Nyxoah S.A."}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2019,9,21]]},"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:sec><jats:title>Background and aim<\/jats:title><jats:p>Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity<jats:italic>via<\/jats:italic>genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6\u2005months post-implantation of a novel device delivering bilateral HNS<jats:italic>via<\/jats:italic>a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio\u2122 system.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea\u2013hypopnoea 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<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03048604\">NCT03048604<\/jats:ext-link>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>22 out of 27 implanted participants (63% male, aged 55.9\u00b112.0\u2005years, body mass index (BMI) 27.4\u00b13.0\u2005kg\u00b7m<jats:sup>\u22122<\/jats:sup>) completed the protocol. At 6\u2005months BMI was unchanged (p=0.85); AHI decreased from 23.7\u00b112.2 to 12.9\u00b110.1\u2005events\u00b7h<jats:sup>\u22121<\/jats:sup>, a mean change of 10.8\u2005events\u00b7h<jats:sup>\u22121<\/jats:sup>(p&lt;0.001); and ODI decreased from 19.1\u00b111.2 to 9.8\u00b16.9\u2005events\u00b7h<jats:sup>\u22121<\/jats:sup>, a mean change of 9.3\u2005events\u00b7h<jats:sup>\u22121<\/jats:sup>(p&lt;0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use &gt;5\u2005days per week, and 77% reported use for &gt;5\u2005h per night. No device-related serious adverse events occurred during the 6-month post-implantation period.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Bilateral HNS using the Genio\u2122 system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.<\/jats:p><\/jats:sec>","DOI":"10.1183\/13993003.01320-2019","type":"journal-article","created":{"date-parts":[[2019,10,10]],"date-time":"2019-10-10T18:34:39Z","timestamp":1570732479000},"page":"1901320","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":133,"title":["Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea"],"prefix":"10.1183","volume":"55","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4490-4138","authenticated-orcid":false,"given":"Peter R.","family":"Eastwood","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maree","family":"Barnes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart G.","family":"MacKay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John R.","family":"Wheatley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Hillman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xu\u00e2n-Lan","family":"Nguy\u00ean","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Lewis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew C.","family":"Campbell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"P\u00e9telle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer H.","family":"Walsh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew C.","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carsten E.","family":"Palme","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Bizon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Meslier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chlo\u00e9","family":"Bertolus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen J.","family":"Maddison","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Laccourreye","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillaume","family":"Raux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katleen","family":"Denoncin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Val\u00e9rie","family":"Attali","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fr\u00e9d\u00e9ric","family":"Gagnadoux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandrine H.","family":"Launois","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2019,10,10]]},"reference":[{"key":"2024102101130544000_55.1.1901320.1","first-page":"1311","article-title":"Obstructive sleep apnea is a common disorder in the population \u2013 a review on the epidemiology of sleep apnea","volume":"7","author":"Franklin","year":"2015","journal-title":"J Thorac Dis"},{"key":"2024102101130544000_55.1.1901320.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2009.04.001"},{"key":"2024102101130544000_55.1.1901320.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2011.01.003"},{"key":"2024102101130544000_55.1.1901320.4","doi-asserted-by":"crossref","unstructured":"Sunwoo BY , Light M , Malhotra A . Strategies to augment adherence in the management of sleep-disordered breathing. Respirology 2019; in press [https:\/\/doi.org.\/10.1111\/resp.13589].","DOI":"10.1111\/resp.13589"},{"key":"2024102101130544000_55.1.1901320.5","doi-asserted-by":"publisher","DOI":"10.1152\/japplphysiol.00423.2013"},{"key":"2024102101130544000_55.1.1901320.6","doi-asserted-by":"publisher","DOI":"10.1001\/archotol.127.10.1216"},{"key":"2024102101130544000_55.1.1901320.7","doi-asserted-by":"crossref","first-page":"1479","DOI":"10.5665\/sleep.1380","article-title":"Treating obstructive sleep apnea with hypoglossal nerve stimulation","volume":"34","author":"Eastwood","year":"2011","journal-title":"Sleep"},{"key":"2024102101130544000_55.1.1901320.8","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMe1314084"},{"key":"2024102101130544000_55.1.1901320.9","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1308659"},{"key":"2024102101130544000_55.1.1901320.10","doi-asserted-by":"crossref","first-page":"194","DOI":"10.1177\/0194599818762383","article-title":"Upper airway stimulation for obstructive sleep apnea: 5-year outcomes","volume":"159","author":"Woodson","year":"2018","journal-title":"Otolaryngol Head Neck Surg"},{"key":"2024102101130544000_55.1.1901320.11","doi-asserted-by":"crossref","first-page":"376","DOI":"10.1111\/j.1525-1403.2012.00514.x","article-title":"Tongue anatomy and physiology, the scientific basis for a novel targeted neurostimulation system designed for the treatment of obstructive sleep apnea","volume":"16","author":"Zaidi","year":"2013","journal-title":"Neuromodulation"},{"key":"2024102101130544000_55.1.1901320.12","doi-asserted-by":"crossref","first-page":"2618","DOI":"10.1002\/lary.25909","article-title":"Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: six-month results","volume":"126","author":"Friedman","year":"2016","journal-title":"Laryngoscope"},{"key":"2024102101130544000_55.1.1901320.13","doi-asserted-by":"crossref","first-page":"433","DOI":"10.5664\/jcsm.2658","article-title":"Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea","volume":"9","author":"Vanderveken","year":"2013","journal-title":"J Clin Sleep Med"},{"key":"2024102101130544000_55.1.1901320.14","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1093\/sleep\/19.2.156","article-title":"The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome","volume":"19","author":"Sher","year":"1996","journal-title":"Sleep"},{"key":"2024102101130544000_55.1.1901320.15","doi-asserted-by":"crossref","first-page":"767","DOI":"10.1007\/s11325-014-0939-3","article-title":"A comparison between the AASM 2012 and 2007 definitions for detecting hypopnea","volume":"18","author":"BaHammam","year":"2014","journal-title":"Sleep Breath"},{"key":"2024102101130544000_55.1.1901320.16","doi-asserted-by":"crossref","first-page":"1593","DOI":"10.5665\/sleep.2226","article-title":"Effects of continuous positive airway pressure on neurocognitive function in obstructive sleep apnea patients: the Apnea Positive Pressure Long-term Efficacy Study (APPLES)","volume":"35","author":"Kushida","year":"2012","journal-title":"Sleep"},{"key":"2024102101130544000_55.1.1901320.17","doi-asserted-by":"publisher","DOI":"10.5665\/sleep.1870"},{"key":"2024102101130544000_55.1.1901320.18","doi-asserted-by":"publisher","DOI":"10.1513\/pats.200708-119MG"},{"key":"2024102101130544000_55.1.1901320.19","doi-asserted-by":"crossref","first-page":"114","DOI":"10.1016\/j.sleep.2019.01.004","article-title":"Short-term CPAP adherence in obstructive sleep apnea: a big data analysis using real world data","volume":"59","author":"Cistulli","year":"2019","journal-title":"Sleep Med"},{"key":"2024102101130544000_55.1.1901320.20","doi-asserted-by":"crossref","first-page":"509","DOI":"10.1002\/lary.26688","article-title":"Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study","volume":"128","author":"Steffen","year":"2018","journal-title":"Laryngoscope"},{"key":"2024102101130544000_55.1.1901320.21","doi-asserted-by":"publisher","DOI":"10.1111\/jsr.12079"},{"key":"2024102101130544000_55.1.1901320.22","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00042412"},{"key":"2024102101130544000_55.1.1901320.23","unstructured":"U.S. Food & Drug Administration. Inspire II Upper Airway Stimulator. Pre Market Approval Number P130008. Docket number 14M-0690. www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpma\/pma.cfm?id=P130008."},{"key":"2024102101130544000_55.1.1901320.24","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2869.2000.00177.x"},{"key":"2024102101130544000_55.1.1901320.25","doi-asserted-by":"crossref","first-page":"711","DOI":"10.1093\/sleep\/30.6.711","article-title":"Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning","volume":"30","author":"Weaver","year":"2007","journal-title":"Sleep"},{"key":"2024102101130544000_55.1.1901320.26","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1016\/j.rmed.2018.06.002","article-title":"Selective upper airway stimulation in older patients","volume":"140","author":"Zhu","year":"2018","journal-title":"Respir Med"},{"key":"2024102101130544000_55.1.1901320.27","doi-asserted-by":"crossref","first-page":"901","DOI":"10.1007\/s11325-017-1519-0","article-title":"Effects of upper-airway stimulation on sleep architecture in patients with obstructive sleep apnea","volume":"21","author":"Hofauer","year":"2017","journal-title":"Sleep Breath"},{"key":"2024102101130544000_55.1.1901320.28","doi-asserted-by":"crossref","first-page":"1970","DOI":"10.1002\/lary.27064","article-title":"Tongue motion variability with changes of upper airway stimulation electrode configuration and effects on treatment outcomes","volume":"128","author":"Steffen","year":"2018","journal-title":"Laryngoscope"},{"key":"2024102101130544000_55.1.1901320.29","doi-asserted-by":"crossref","first-page":"553","DOI":"10.1007\/s11325-015-1237-4","article-title":"Functional outcome of tongue motions with selective hypoglossal nerve stimulation in patients with obstructive sleep apnea","volume":"20","author":"Heiser","year":"2016","journal-title":"Sleep Breath"},{"issue":"Suppl. 7","key":"2024102101130544000_55.1.1901320.30","first-page":"S12","article-title":"Updates of operative techniques for upper airway stimulation","volume":"126","author":"Heiser","year":"2016","journal-title":"Laryngoscope"},{"key":"2024102101130544000_55.1.1901320.31","doi-asserted-by":"publisher","DOI":"10.1152\/jn.00051.2015"},{"key":"2024102101130544000_55.1.1901320.32","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00059414"},{"key":"2024102101130544000_55.1.1901320.33","doi-asserted-by":"crossref","first-page":"E378","DOI":"10.1002\/lary.26487","article-title":"Palatoglossus coupling in selective upper airway stimulation","volume":"127","author":"Heiser","year":"2017","journal-title":"Laryngoscope"},{"key":"2024102101130544000_55.1.1901320.34","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1007\/s11325-016-1383-3","article-title":"Sonographic evaluation of tongue motions during upper airway stimulation for obstructive sleep apnea \u2013 a pilot study","volume":"21","author":"Hofauer","year":"2017","journal-title":"Sleep Breath"},{"issue":"Suppl. 7","key":"2024102101130544000_55.1.1901320.35","first-page":"S22","article-title":"Advanced titration to treat a floppy epiglottis in selective upper airway stimulation","volume":"126","author":"Heiser","year":"2016","journal-title":"Laryngoscope"},{"key":"2024102101130544000_55.1.1901320.36","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2869.2008.00647.x"},{"key":"2024102101130544000_55.1.1901320.37","doi-asserted-by":"crossref","first-page":"190","DOI":"10.1152\/jappl.1998.84.1.190","article-title":"Effects of NREM sleep on dynamic within-breath changes in upper airway patency in humans","volume":"84","author":"Morrell","year":"1998","journal-title":"J Appl Physiol"},{"key":"2024102101130544000_55.1.1901320.38","doi-asserted-by":"crossref","first-page":"1504","DOI":"10.1152\/jappl.1993.74.4.1504","article-title":"Dynamic imaging of the upper airway during respiration in normal subjects","volume":"74","author":"Schwab","year":"1993","journal-title":"J Appl Physiol"},{"key":"2024102101130544000_55.1.1901320.39","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.158.6.9712107"},{"key":"2024102101130544000_55.1.1901320.40","doi-asserted-by":"crossref","first-page":"478","DOI":"10.1152\/jappl.1996.80.2.478","article-title":"Relationship between velopharyngeal dimensions and palatal EMG during progressive hypercapnia","volume":"80","author":"Launois","year":"1996","journal-title":"J Appl Physiol"},{"key":"2024102101130544000_55.1.1901320.41","doi-asserted-by":"publisher","DOI":"10.1152\/japplphysiol.00942.2001"},{"key":"2024102101130544000_55.1.1901320.42","doi-asserted-by":"publisher","DOI":"10.1136\/thx.2005.052084"}],"container-title":["European Respiratory Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1183\/13993003.01320-2019","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T07:24:11Z","timestamp":1740381851000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.ersnet.org\/lookup\/doi\/10.1183\/13993003.01320-2019"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10,10]]},"references-count":42,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2020,1,9]]},"published-print":{"date-parts":[[2020,1]]}},"alternative-id":["10.1183\/13993003.01320-2019"],"URL":"https:\/\/doi.org\/10.1183\/13993003.01320-2019","relation":{},"ISSN":["0903-1936","1399-3003"],"issn-type":[{"value":"0903-1936","type":"print"},{"value":"1399-3003","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,10,10]]}}}