Department of Otorhinolaryngology, Head and Neck Surgery, Technical University Munich, Ismaninger Str. 22, 81675, Munich, Germany.
Translational Neurosciences, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Sleep Breath. 2023 May;27(2):693-701. doi: 10.1007/s11325-022-02663-6. Epub 2022 Jul 2.
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.
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.
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.
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.
ClinicalTrial.gov Identifier: NCT03756805.
舌下神经刺激(HNS)已被证明可有效治疗阻塞性睡眠呼吸暂停(OSA)。本研究的目的是比较 HNS 与正压通气(PAP)治疗在以下方面的疗效参数:(1)嗜睡;(2)呼吸暂停低通气指数(AHI);(3)有效性。
采用最近邻算法的倾向评分匹配,比较真实环境中 HNS 和 PAP 治疗的结果。在开始 OSA 治疗时收集数据,包括人口统计学数据、Epworth 嗜睡量表(ESS)、AHI 和客观依从性数据。为了评估整体治疗效果,计算了平均疾病缓解率(MDA)。
在连续接受治疗的 227 例患者中,有 126 例可以在年龄、体重指数和 AHI 方面进行 1:1 匹配。匹配后,两组间无统计学差异。两组患者在 12 个月时均出现了有临床意义的症状改善,但 HNS 治疗组 ESS 改善程度更大(8.0±5.1 分 vs. 3.9±6.8 分;p=0.042)。两组患者治疗后 AHI 均显著降低(HNS:8.1±6.3/h;PAP:6.6±8.0/h;p<0.001)。HNS 治疗组患者 12 个月时的依从性高于 PAP 治疗组(5.0±2.6 小时/夜;4.0±2.1 小时/夜),但差异无统计学意义。采用 MDA 计算的总体疗效,HNS 治疗组为 59%,PAP 治疗组为 51%。
与 PAP 治疗相比,HNS 治疗组患者的日间嗜睡改善更为显著,而 AHI 均值降低和总体疗效在两种治疗方法中相当。
ClinicalTrials.gov 标识符:NCT03756805。