Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
J Sleep Res. 2014 Feb;23(1):77-83. doi: 10.1111/jsr.12079. Epub 2013 Sep 4.
Reduced upper airway muscle activity during sleep is a key contributor to obstructive sleep apnea pathogenesis. Hypoglossal nerve stimulation activates upper airway dilator muscles, including the genioglossus, and has the potential to reduce obstructive sleep apnea severity. The objective of this study was to examine the safety, feasibility and efficacy of a novel hypoglossal nerve stimulation system (HGNS; Apnex Medical, St Paul, MN, USA) in treating obstructive sleep apnea at 12 months following implantation. Thirty-one subjects (35% female, age 52.4 ± 9.4 years) with moderate to severe obstructive sleep apnea and unable to tolerate positive airway pressure underwent surgical implantation and activation of the hypoglossal nerve stimulation system in a prospective single-arm interventional trial. Primary outcomes were changes in obstructive sleep apnea severity (apnea-hypopnea index, from in-laboratory polysomnogram) and sleep-related quality of life [Functional Outcomes of Sleep Questionnaire (FOSQ)]. Hypoglossal nerve stimulation was used on 86 ± 16% of nights for 5.4 ± 1.4 h per night. There was a significant improvement (P < 0.001) from baseline to 12 months in apnea-hypopnea index (45.4 ± 17.5 to 25.3 ± 20.6 events h(-1) ) and Functional Outcomes of Sleep Questionnaire score (14.2 ± 2.0 to 17.0 ± 2.4), as well as other polysomnogram and symptom measures. Outcomes were stable compared with 6 months following implantation. Three serious device-related adverse events occurred: an infection requiring device removal; and two stimulation lead cuff dislodgements requiring replacement. There were no significant adverse events with onset later than 6 months following implantation. Hypoglossal nerve stimulation demonstrated favourable safety, feasibility and efficacy.
睡眠时上气道肌肉活动减少是导致阻塞性睡眠呼吸暂停发病的一个关键因素。舌下神经刺激激活上气道扩张肌，包括颏舌肌，并有降低阻塞性睡眠呼吸暂停严重程度的潜力。本研究的目的是在植入后 12 个月，检查一种新型舌下神经刺激系统（HGNS；Apnex Medical，明尼苏达州圣保罗）治疗阻塞性睡眠呼吸暂停的安全性、可行性和疗效。31 名（35%为女性，年龄 52.4±9.4 岁）中重度阻塞性睡眠呼吸暂停且不能耐受正压通气的患者接受了前瞻性单臂介入试验中的手术植入和舌下神经刺激系统激活。主要结局是阻塞性睡眠呼吸暂停严重程度的变化（从实验室多导睡眠图中的呼吸暂停低通气指数）和睡眠相关生活质量[睡眠功能结局问卷（FOSQ）]。舌下神经刺激在 86±16%的夜间使用，每晚 5.4±1.4 小时。与基线相比，呼吸暂停低通气指数（从 45.4±17.5 降至 25.3±20.6 事件/h）和睡眠功能结局问卷评分（从 14.2±2.0 升至 17.0±2.4）均有显著改善（P<0.001），其他多导睡眠图和症状测量指标也有所改善。与植入后 6 个月相比，结果保持稳定。发生了 3 起与设备相关的严重不良事件：需要移除设备的感染；和 2 起刺激导联袖带脱位需要更换。植入后 6 个月后没有发生明显的不良事件。舌下神经刺激显示出良好的安全性、可行性和疗效。
