Dept. of Pneumology, Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium..
Eur Respir J. 2013 Feb;41(2):360-7. doi: 10.1183/09031936.00042412. Epub 2012 May 17.
Continuous positive airway pressure (CPAP) is an effective but cumbersome treatment for obstructive sleep apnoea (OSA). Noncompliant patients need alternative therapies. We studied a tongue neurostimulation approach: targeted hypoglossal neurostimulation (THN) therapy with the aura6000™ System. A multi-contact electrode positioned around the main trunk of the twelfth nerve connected to an implanted pulse generator stimulates segments of the nerve, activating dilator muscles. The primary objective was to improve the polysomnographically determined apnoea/hypopnoea index (AHI) at 3 months, and maintain the improvement after 12 months of treatment. 13 out of 14 operated patients were successfully implanted. At 12 months, the AHI decreased from 45±18 to 21±17, a 53% reduction (p<0.001). The 4% oxygen desaturation index fell from 29±20 to 15±16 and the arousal index from 37±13 to 25±14, both p<0.001. The Epworth sleepiness scale decreased from 11±7 to 8±4 (p=0.09). THN was neither painful nor awakened patients, who all complied with therapy. There were two transient tongue paresis. The present study represents the longest study of any hypoglossal neurostimulation reported to date. We conclude that THN is safe and effective to treat OSA in patients not compliant with CPAP.
持续气道正压通气（CPAP）是治疗阻塞性睡眠呼吸暂停（OSA）的有效但繁琐的方法。不依从的患者需要替代疗法。我们研究了一种舌神经刺激方法：靶向舌下神经刺激（THN）疗法，使用 aura6000™系统。一个多接触电极围绕第十二神经的主干放置，连接到植入式脉冲发生器，刺激神经的节段，激活扩张肌。主要目标是在 3 个月时改善多导睡眠图确定的呼吸暂停/低通气指数（AHI），并在 12 个月的治疗后保持改善。14 例手术患者中有 13 例成功植入。12 个月时，AHI 从 45±18 降至 21±17，降低了 53%（p<0.001）。4%氧减指数从 29±20 降至 15±16，觉醒指数从 37±13 降至 25±14，均 p<0.001。嗜睡量表评分从 11±7 降至 8±4（p=0.09）。THN 既不痛苦也不会唤醒患者，所有患者都能配合治疗。有 2 例短暂性舌麻痹。本研究代表了迄今为止报告的任何舌下神经刺激最长的研究。我们得出结论，THN 治疗 CPAP 不依从的 OSA 患者是安全有效的。
