％0期刊论文％A伊斯特伍德，彼得R.％巴恩斯，MAREE％A·麦凯，斯图尔特G.％A韦奕礼，约翰R.％A希尔曼，大卫R.％阿阮，宣兰％路易斯，理查德％甲坎贝尔，马修C.％APételle，鲍里斯％A沃尔什，珍H.％A琼斯，安德鲁C.％A帕尔梅，卡斯滕E.％A BIZON，阿兰·％A Meslier，尼科尔％A Bertolus批发％A麦迪逊凯瑟琳J.％A Laccourreye，劳伦％A RAUX纪尧姆％A Denoncin，Katleen％A阿塔利瓦莱丽％A Gagnadoux，弗雷德里克％A Launois，和Sandrine H.％T双侧舌下神经刺激治疗的成人阻塞性睡眠呼吸暂停％d 2020％R 10.1183 / 13993003.01320-2019％Ĵ欧洲呼吸杂志％P 1901320％V 55％N 1％X背景与目的舌下神经刺激（HNS）经由颏舌肌活化降低阻塞性睡眠呼吸暂停（OSA）的严重程度和降低上气道溃散。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.Methods 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–hypopnoea 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.Results 22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m−2) 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·h−1, a mean change of 10.8 events·h−1 (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h−1, a mean change of 9.3 events·h−1 (p<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 >5 days per week, and 77% reported use for >5 h per night. No device-related serious adverse events occurred during the 6-month post-implantation period.Conclusions Bilateral HNS using the Genio™ 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.A new method of hypoglossal nerve stimulation to treat sleep apnoea does so bilaterally via an implanted neurostimulator activated externally. Its simplicity and relative non-invasiveness have not compromised its effectiveness relative to older methods. http://bit.ly/2lDCeif %U //www.qdcxjkg.com/content/erj/55/1/1901320.full.pdf