Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea
Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea
复制标题
DOI：
10.1183/13993003.01320-2019
复制
发表时间：
2020-01-01
影响因子：
24.3
通讯作者：
Launois, Sandrine H.
中科院分区：
文献类型：
--
作者：
Eastwood, Peter R.;Barnes, Maree;Launois, Sandrine H.
背景和目的：舌下神经刺激（HNS）通过激活颏舌肌和降低上气道通透性来降低阻塞性睡眠呼吸暂停（OSA）的严重程度。这项研究评估了安全性和有效性，在6个月后植入的一种新的设备提供双边HNS通过一个小的植入式电极激活的一个单位穿在外面，治疗OSA：GenioT system.Methods：这一前瞻性，开放标签，非随机，单臂治疗研究在三个国家（澳大利亚，法国和英国）的八个中心进行。主要结局为器械相关严重不良事件的发生率和呼吸暂停-呼吸不足指数（AHI）的变化。次要结局是4%氧减饱和指数（ODI）的变化。其他结果包括嗜睡，生活质量，打鼾和设备使用的措施。该试验注册于ClinicalTrials.gov，编号NCT 03048604。结果：27名植入受试者中有22名（63%为男性，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无变化（p=0.85）; AHI从23.7 +/- 12.2降至12.9 +/- 10.1起事件.h（-1），平均变化10.8起事件.h（-1）（p每晚5 h）。在6个月的植入后periods.Conclusions：双侧HNS使用GenioT系统降低了OSA的严重程度，提高了生活质量，没有设备相关的并发症。尽管植入组件最少且刺激算法简单，但结果与先前发表的HNS系统相当。
Background and aim: Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. 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 GenioT 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) ( p5 h per night. No device-related serious adverse events occurred during the 6-month post-implantation period.Conclusions: Bilateral HNS using the GenioT 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.