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催眠神经刺激和阻塞性睡眠呼吸暂停患者的心血管结果:一项随机临床试验

Raj C Dedhia^1,2, Donald L Bliwise³, Arshed A Quyyumi⁴

¹Department of Otorhinolaryngology, University of Pennsylvania, Philadelphia.

JAMA otolaryngology-- head & neck surgery

|November 30, 2023

概括

在患有阻塞性睡眠呼吸暂停 (OSA) 的患者中,低分泌神经刺激 (HGNS) 疗法没有显著改变心血管指标,如血压. 未来的试验应该纳入从这个假控制研究中学到的经验教训.

科学领域:

心血管医学心血管医学
睡眠医学睡眠医学
医疗器械医疗器械

背景情况:

阻塞性睡眠呼吸暂停 (OSA) 与心血管并发症有关.
低音神经刺激 (HGNS) 是适度至重度OSA的治疗方法.
HGNS对心血管的影响需要通过假控制试验进行进一步的调查.

研究的目的:

评估治疗性HGNS与假药治疗对OSA患者血压,同情活动和血管功能的影响.
为了在随机交叉试验中比较活跃和假冒的HGNS疗法之间的心血管终点.

主要方法:

一个双盲,假控制,随机交叉试验,涉及60名成年OSA患者,植入了HGNS设备.
参与者接受了4周的活跃HGNS和4周的假HGNS治疗.
主要结局是24小时缩血压的变化;次要结局包括排泄前期 (PEP) 和流量介导扩张 (FMD).

主要成果:

在主动和假的HGNS治疗之间,没有发现平均24小时缩血压的显著差异.
预喷射期 (PEP) 和流媒体扩张 (FMD) 也显示两种治疗臂之间没有显著差异.
每个协议的分析表明,在一个具有显著的呼吸暂停-呼吸暂停指数减少的子组中,存在潜在的差异.

结论:

这项随机临床试验在OSA患者的活性和虚假HGNS治疗之间没有发现心血管指标的显著差异.
获得了方法学的见解,以指导未来的HGNS随机临床试验.
需要进一步的研究才能充分理解HGNS治疗对心血管的影响.

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