Purpose

Hypoglossal nerve stimulation (HNS) has been shown to treat obstructive sleep apnea (OSA) effectively. The aim of this study was to compare HNS with positive airway pressure (PAP) treatment regarding outcome parameters: (1) sleepiness, (2) apnea–hypopnea index (AHI), and (3) effectiveness.

Methods

Propensity score matching with nearest neighbor algorithm was used to compare outcomes of HNS and PAP therapy in a real-world setting. Data were collected at baseline and 12 months after initiating OSA treatment including demographics, Epworth Sleepiness Scale (ESS), AHI, and objective adherence data. To account for overall treatment efficacy, the mean disease alleviation (MDA) was calculated.

Results

Of 227 patients who received treatment consecutively, 126 could be matched 1:1 with regard to age, body mass index, and AHI. After matching, no statistically significant differences between the groups were found. A clinically important symptom improvement was seen at 12 months in both cohorts, though there was a greater difference in ESS improvement in patients treated with HNS (8.0 ± 5.1 points vs. 3.9 ± 6.8 points; p = 0.042). In both groups, mean posttreatment AHI was significantly reduced (HNS: 8.1 ± 6.3/h; PAP: 6.6 ± 8.0/h; p < 0.001). Adherence after 12 months among patients treated with HNS was higher than in those receiving PAP therapy (5.0 ± 2.6 h/night; 4.0 ± 2.1 h/night) but not with statistical significance. Overall effectiveness calculated with the MDA was 59% in patients treated with HNS compared to 51% receiving PAP.

Conclusion

Patients treated with HNS therapy had significantly greater improvements in daytime sleepiness compared to PAP therapy, while the mean reduction of AHI and overall effectiveness were comparable for both treatments.

Trial registration

ClinicalTrial.gov Identifier: NCT03756805.

中文翻译：

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舌下神经刺激与气道正压通气治疗阻塞性睡眠呼吸暂停

目的

舌下神经刺激 (HNS) 已被证明可以有效治疗阻塞性睡眠呼吸暂停 (OSA)。本研究的目的是比较 HNS 与气道正压通气 (PAP) 治疗的结果参数：(1) 嗜睡，(2) 呼吸暂停低通气指数 (AHI)，以及 (3) 有效性。

方法

使用最近邻算法的倾向得分匹配来比较真实世界环境中 HNS 和 PAP 治疗的结果。在基线和开始 OSA 治疗后 12 个月收集数据，包括人口统计学、Epworth 嗜睡量表 (ESS)、AHI 和客观依从性数据。为了说明整体治疗效果，计算了平均疾病缓解 (MDA)。

结果

在连续接受治疗的 227 名患者中，126 名在年龄、体重指数和 AHI 方面可以 1:1 匹配。匹配后，发现各组之间没有统计学上的显着差异。两个队列在 12 个月时均观察到具有临床意义的症状改善，但接受 HNS 治疗的患者的 ESS 改善差异更大（8.0 ± 5.1 分对 3.9 ± 6.8 分；p = 0.042 ）  。在两组中，平均治疗后 AHI 显着降低（HNS：8.1 ± 6.3/h；PAP：6.6 ± 8.0/h；p < 0.001)。接受 HNS 治疗的患者在 12 个月后的依从性高于接受 PAP 治疗的患者（5.0 ± 2.6 小时/晚；4.0 ± 2.1 小时/晚），但没有统计学意义。用 MDA 计算的总体有效性在接受 HNS 治疗的患者中为 59%，而接受 PAP 治疗的患者为 51%。

结论

与 PAP 治疗相比，接受 HNS 治疗的患者在白天嗜睡方面有明显更大的改善，而两种治疗的 AHI 平均降低和总体有效性相当。

试用注册

ClinicalTrial.gov 标识符：NCT03756805。