TY - T1的双边舌下神经刺激治疗成人阻塞性睡眠呼吸暂停的JF -欧洲呼吸杂志》乔和J - 10.1183/13993003.01320 -2019欧元六世- 55 - 1 SP - 1901320 AU -伊斯特伍德,Peter r . AU -巴恩斯,Maree AU -麦凯,斯图尔特·g . AU -惠特利(John r . AU -希尔曼,David r . AU,阮Xuan-Lan AU -刘易斯,理查德AU -坎贝尔,马修·c . AU - Petelle鲍里斯AU -沃尔什,詹妮弗·h . AU -琼斯,安德鲁·c·盟——金棕榈奖,Carsten e . AU - Bizon阿兰AU - Meslier,妮可AU - Bertolus,克洛艾盟——麦迪森,凯瑟琳·j . AU - Laccourreye Laurent盟——Raux Guillaume盟——Denoncin Katleen盟领袖,瓦莱丽盟——Gagnadoux Frederic AU - Launois Sandrine h . Y1 - 2020/01/01 UR - //www.qdcxjkg.com/content/55/1/1901320.abstract N2 -背景和目的舌下神经刺激(hn)降低阻塞性睡眠呼吸暂停(OSA)严重程度通过genioglossus肌肉活动和减少上呼吸道折叠。本研究评估了一种新型装置植入6个月后的安全性和有效性，该装置通过外部佩戴的装置激活的小电极植入双侧HNS，用于治疗OSA: Genio™系统。方法在三个国家(澳大利亚、法国和英国)的八个中心进行了这项前瞻性、开放标签、非随机、单臂治疗研究。主要结果是设备相关的严重不良事件的发生率和呼吸暂停-垂体指数(AHI)的变化。次要结果是4%的氧去饱和指数(ODI)的变化。其他结果包括测量嗜睡、生活质量、打鼾和使用电子设备。该试验在ClinicalTrials.gov上注册，编号为NCT03048604。结果27例植入患者中有22例(63%男性，年龄55.9±12.0岁，体重指数(BMI) 27.4±3.0 kg·m−2)完成了方案。6个月时BMI不变(p=0.85);AHI从23.7±12.2下降到12.9±10.1事件·h−1，平均变化10.8事件·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 ER -