Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial.

IF 3.5 3区医学 Q1 CLINICAL NEUROLOGY

Journal of Clinical Sleep Medicine Pub Date : 2025-07-24 DOI:10.5664/jcsm.11822

B Tucker Woodson, David T Kent, Colin Huntley, Melyssa K Hancock, Douglas J Van Daele, Maurits S Boon, Tod C Huntley, Sam Mickelson, M Boyd Gillespie, Maria V Suurna, Ashutosh Kacker, Asim Roy, Stuart MacKay, Kirk P Withrow, Raj C Dedhia, Phillip Huyett, Clemens Heiser, Sylvie di Nicola, Fatima Makori, Olivier M Vanderveken, Tapan A Padyha, Ulysses J Magalang, Eugene Chio, Eric J Kezirian, Richard Lewis

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引用次数: 0

Abstract

Study objectives: To evaluate the safety and efficacy of a novel bilateral hypoglossal nerve stimulation (HNS_BL) device for the treatment of OSA.

Methods: Adult patients with moderate-to-severe OSA who refused, failed, or did not tolerate positive airway pressure therapy underwent implantation and nightly use of HNS_BL. The co-primary endpoints at 12 months were 1) a minimum of 50% reduction in the 4% apnea-hypopnea index (AHI) from baseline with a final AHI of less than 20 events/h, and 2) a minimum of 25% reduction in the 4% oxygen desaturation index (ODI). Objective secondary endpoints included changes in mean AHI, ODI, and sleep time with blood oxygen saturation less than 90% (T90). Subjective secondary endpoints included changes in Epworth sleepiness score (ESS), the short Functional Outcomes of Sleep Questionnaire (FOSQ-10) score, the Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) score, and bedpartner assessment of snoring.

Results: HNS_BL was implanted in 113 participants. Eleven SAEs occurred in 10 (8.7%) participants. The co-primary endpoints were completed by 89 (77.4%) participants. AHI and ODI responses were achieved in 63.5% (73/115, p = 0.002) and 71.3% (82/115, p< 0.001), respectively. Secondary endpoint analysis revealed significant changes in mean AHI (-18.3±11.8 events/h, p<0.001), ODI (-17.7±14.6 events/h, p<0.001), and T90 (6.9±10.7%, p<0.001). Significant changes were observed in all secondary endpoints (p<0.001).

Conclusions: This pivotal clinical trial of HNS_BL demonstrated an acceptable safety profile with clinically significant improvements in OSA severity and quality-of-life metrics. HNS_BL is a promising new treatment option for select patients with OSA.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: Dual-sided Hypoglossal NeRvE StimulAtion for the TreatMent of Obstructive Sleep Apnea (DREAM); Identifier: NCT03868618; URL: https://clinicaltrials.gov/study/NCT03868618.

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双侧舌下神经刺激治疗阻塞性睡眠呼吸暂停：一项非随机临床试验。

研究目的：评价一种新型双侧舌下神经刺激（HNSBL）装置治疗OSA的安全性和有效性。方法：拒绝、失败或不能耐受气道正压治疗的中重度OSA成年患者接受植入和夜间使用HNSBL。12个月时的共同主要终点是1)4%呼吸暂停低通气指数（AHI）较基线至少降低50%，最终AHI小于20事件/小时，2)4%氧去饱和指数（ODI）至少降低25%。客观次要终点包括血氧饱和度低于90% （T90）时平均AHI、ODI和睡眠时间的变化。主观次要终点包括Epworth嗜睡评分（ESS）、短睡眠功能结局问卷（FOSQ-10）评分、夜间梗阻症状及相关事件（SNORE-25）评分的变化，以及床伴对打鼾的评估。结果：113例患者植入HNSBL。10例（8.7%）参与者发生11例急性呼吸道感染。共有89名（77.4%）参与者完成了共同主要终点。AHI和ODI的应答率分别为63.5% （73/115,p = 0.002）和71.3% （82/115,p< 0.001）。次要终点分析显示，平均AHI有显著变化（-18.3±11.8事件/小时）。结论：这项关键性的HNSBL临床试验显示出可接受的安全性，在OSA严重程度和生活质量指标方面有临床显着改善。对于OSA患者来说，HNSBL是一种很有前景的新治疗选择。临床试验注册：注册：ClinicalTrials.gov；双侧舌下神经刺激治疗阻塞性睡眠呼吸暂停（DREAM）标识符:NCT03868618;URL: https://clinicaltrials.gov/study/NCT03868618。

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来源期刊

Journal of Clinical Sleep Medicine CLINICAL NEUROLOGY-

CiteScore

6.20

自引率

7.00%

发文量

321

审稿时长

1 months

期刊介绍： Journal of Clinical Sleep Medicine focuses on clinical sleep medicine. Its emphasis is publication of papers with direct applicability and/or relevance to the clinical practice of sleep medicine. This includes clinical trials, clinical reviews, clinical commentary and debate, medical economic/practice perspectives, case series and novel/interesting case reports. In addition, the journal will publish proceedings from conferences, workshops and symposia sponsored by the American Academy of Sleep Medicine or other organizations related to improving the practice of sleep medicine.