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经口清醒状态下神经肌肉电刺激治疗轻中度阻塞性睡眠呼吸暂停。

Transoral awake state neuromuscular electrical stimulation therapy for mild obstructive sleep apnea.

机构信息

Division of Pulmonary, Critical Care, Sleep Medicine and Physiology, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92121, USA.

VA San Diego Healthcare System, San Diego, CA, USA.

出版信息

Sleep Breath. 2023 May;27(2):527-534. doi: 10.1007/s11325-022-02644-9. Epub 2022 May 27.

Abstract

INTRODUCTION

Obstructive sleep apnea (OSA) is a common disorder with major neurocognitive and cardiovascular sequelae. The treatment of symptomatic patients with mild OSA remains controversial given that adherence to positive airway pressure (PAP) has historically been suboptimal. With this notion in mind, we assessed a daily transoral neuromuscular electrical stimulation (NMES) device for individuals with mild OSA.

METHODS

The sample represents a subset of participants with a baseline AHI 5-14.9 events/hour, drawn from a parent study which also included participants with primary snoring. Outcome measures for the current study included changes in apnea-hypopnea index (AHI), Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI) and snoring levels before and after use of the NMES.  RESULTS: Among 65 participants (68% men) with median age of 49 years (range 24 to 79) and median BMI of 27.7 kg/m (range 20 to 34), the NMES device was used daily for 6 weeks. We observed a significant improvement in the AHI from 10.2 to 6.8 events/hour among all participants and from 10.4 to 5.0 events/h among responders. Statistically significant improvements in the ESS, PSQI, objectively measured snoring, and bed partner-reported snoring were observed. Adherence among all participants was 85%.

DISCUSSION

This NMES device has the benefit of being a treatment modality of daytime therapy which confers a high level of tolerability and patient acceptance. It alleviates the need for an in situ device during sleep and leads to improvements in OSA severity, snoring, and subjective sleep metrics, potentially crucial in mild OSA. Further studies are needed to define which individuals may benefit most from the device across the wider spectrum of OSA severity and assess long-term therapeutic outcomes.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03829956.

摘要

介绍

阻塞性睡眠呼吸暂停(OSA)是一种常见的疾病,会导致严重的神经认知和心血管后果。对于症状性轻度 OSA 患者的治疗仍然存在争议,因为历史上对正压通气(PAP)的依从性一直不理想。考虑到这一点,我们评估了一种用于轻度 OSA 患者的每日经口神经肌肉电刺激(NMES)设备。

方法

本研究的样本代表了基线 AHI 为 5-14.9 事件/小时的参与者亚组,来自一项也包括原发性打鼾参与者的母研究。当前研究的结果测量包括使用 NMES 前后的呼吸暂停-低通气指数(AHI)、嗜睡量表(ESS)、匹兹堡睡眠质量指数(PSQI)和打鼾水平的变化。

结果

在 65 名参与者(68%为男性)中,中位年龄为 49 岁(范围 24 至 79 岁),中位 BMI 为 27.7kg/m(范围 20 至 34),NMES 设备每天使用 6 周。我们观察到所有参与者的 AHI 从 10.2 降至 6.8 事件/小时,应答者的 AHI 从 10.4 降至 5.0 事件/小时。ESS、PSQI、客观测量的打鼾和床伴报告的打鼾均有显著改善。所有参与者的依从率为 85%。

讨论

这种 NMES 设备的优点是作为日间治疗的一种治疗方式,具有很高的耐受性和患者接受度。它减轻了睡眠期间对原位设备的需求,并导致 OSA 严重程度、打鼾和主观睡眠指标的改善,这在轻度 OSA 中可能至关重要。需要进一步研究来确定在更广泛的 OSA 严重程度范围内,哪些个体可能从该设备中获益最大,并评估长期治疗效果。

试验注册

ClinicalTrials.gov 标识符:NCT03829956。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cfc2/10212854/a700a69738ea/11325_2022_2644_Fig1_HTML.jpg

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