Woodson B Tucker, Suurna Maria V, Gillespie M Boyd, Huntley Tod C, Hancock Melyssa, Santos Angela, Subbaroyan Jeyakumar, Makori Fatima, Fesneau Grégoire, Heiser Clemens, Kent David T
Department of Otolaryngology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Department of Otolaryngology-Head and Neck Surgery, University of Miami, Miami, Florida, USA.
BMJ Open. 2024 Dec 20;14(12):e085218. doi: 10.1136/bmjopen-2024-085218.
Obstructive sleep apnoea (OSA) is characterised by blood oxygen desaturations and sleep disruptions manifesting undesirable consequences. Existing treatments including oral appliances, positive airway pressure (PAP) therapy and surgically altering the anatomy of the pharynx have drawbacks including poor long-term adherence or often involving irreversible, invasive procedures. Bilateral hypoglossal nerve stimulation (HNS) is a new treatment for managing OSA, and this study is intended to determine whether an HNS system is a safe and effective treatment option for adults with OSA.
This is a pivotal, multicentre, prospective, single-arm study of HNS in PAP-intolerant adults with moderate to severe OSA. The device is activated 2 months after implantation with stimulation settings optimised before the final 12-month sleep study. At 12 months, the two coprimary effectiveness endpoints are the percentage of responders based on reduction in the Apnoea-Hypoponea Index, with hypopnoeas associated with 4% oxyhaemoglobin desaturation, and the Oxygen Desaturation Index, using drops in oxygen concentration >4% from baseline (ODI4). Secondary effectiveness endpoints include mean changes in quality-of-life assessments (daytime sleepiness and its effect on activities of daily living, OSA-specific quality of life, daytime sleepiness), levels of intermittent hypoxia, change in hypoxaemic burden and OSA severity.
The Food and Drug Administration, Advarra Institutional Review Board (IRB), University of Tennessee HSC IRB, University of Pennsylvania IRB, Weill Cornell Medicine IRB, Medical College of Wisconsin/Froedert Hospital, Human Research Protections Programme Vanderbilt University, St. Vincent's Hospital Melbourne Human Research Ethics Committee, Ethisch Comite Universitair Ziekenhuis Antwerpen and Technische Universitat Munchen reviewed and approved this protocol. Study results will be disseminated through journal publications, updates to ClinicalTrials.gov and the Nyxoah website, and presentations at meetings and conferences.
NCT03868618.
阻塞性睡眠呼吸暂停（OSA）的特征是血氧饱和度下降和睡眠中断，会产生不良后果。现有的治疗方法包括口腔矫治器、气道正压通气（PAP）治疗以及通过手术改变咽部解剖结构，但这些方法存在缺点，如长期依从性差，或通常涉及不可逆的侵入性手术。双侧舌下神经刺激（HNS）是一种治疗OSA的新方法，本研究旨在确定HNS系统对于成年OSA患者是否是一种安全有效的治疗选择。
这是一项针对不耐受PAP的中重度OSA成年患者进行的HNS关键、多中心、前瞻性单臂研究。植入装置2个月后激活，在最后的12个月睡眠研究前优化刺激设置。12个月时，两个共同主要疗效终点是基于呼吸暂停低通气指数降低的反应者百分比（低通气与4%氧合血红蛋白饱和度下降相关），以及氧饱和度指数（使用氧浓度较基线下降>4%，即ODI4）。次要疗效终点包括生活质量评估的平均变化（日间嗜睡及其对日常生活活动的影响、OSA特异性生活质量、日间嗜睡）、间歇性缺氧水平、低氧血症负担变化和OSA严重程度。
美国食品药品监督管理局、Advarra机构审查委员会（IRB）、田纳西大学健康科学中心IRB、宾夕法尼亚大学IRB、威尔康奈尔医学院IRB、威斯康星医学院/弗罗伊德特医院、范德比尔特大学人类研究保护项目、墨尔本圣文森特医院人类研究伦理委员会、安特卫普大学医院伦理委员会和慕尼黑工业大学对本方案进行了审查并批准。研究结果将通过期刊发表、更新ClinicalTrials.gov和Nyxoah网站以及在会议上进行展示的方式进行传播。
NCT03868618。
