Heiser Clemens, Steffen Armin, Hofauer Benedikt, Mehra Reena, Strollo Patrick J, Vanderveken Olivier M, Maurer Joachim T
Department of Otorhinolaryngology/Head and Neck Surgery, Klinikum Rechts der Isar, Technical University of Munich, 81675 München, Germany.
Department of Otorhinolaryngology/Head and Neck Surgery, University of Luebeck, 23562 Luebeck, Germany.
J Clin Med. 2021 Jun 29;10(13):2880. doi: 10.3390/jcm10132880.
Several single-arm prospective studies have demonstrated the safety and effectiveness of upper airway stimulation (UAS) for obstructive sleep apnea. There is limited evidence from randomized, controlled trials of the therapy benefit in terms of OSA burden and its symptoms.
We conducted a multicenter, double-blinded, randomized, sham-controlled, crossover trial to examine the effect of therapeutic stimulation () versus sham stimulation () on the apnea-hypopnea index (AHI) and the Epworth Sleepiness Scale (ESS). We also examined the Functional Outcomes of Sleep Questionnaire (FOSQ) on sleep architecture. We analyzed crossover outcome measures after two weeks using repeated measures models controlling for treatment order.
The study randomized 89 participants 1:1 to (45) versus (44). After one week, the AHI response rate was 76.7% with and 29.5% with , a difference of 47.2% (95% CI: 24.4 to 64.9, < 0.001) between the two groups. Similarly, ESS was 7.5 ± 4.9 with and 12.0 ± 4.3 with , with a significant difference of 4.6 (95% CI: 3.1 to 6.1) between the two groups. The crossover phase showed no carryover effect. Among 86 participants who completed both phases, the treatment difference between vs. for AHI was -15.5 (95% CI -18.3 to -12.8), for ESS it was -3.3 (95% CI -4.4 to -2.2), and for FOSQ it was 2.1 (95% CI 1.4 to 2.8). UAS effectively treated both REM and NREM sleep disordered breathing.
In comparison with sham stimulation, therapeutic UAS reduced OSA severity, sleepiness symptoms, and improved quality of life among participants with moderate-to-severe OSA.
多项单臂前瞻性研究已证明上气道刺激（UAS）治疗阻塞性睡眠呼吸暂停的安全性和有效性。关于该疗法在阻塞性睡眠呼吸暂停负担及其症状方面的益处，随机对照试验的证据有限。
我们进行了一项多中心、双盲、随机、假刺激对照的交叉试验，以研究治疗性刺激（）与假刺激（）对呼吸暂停低通气指数（AHI）和爱泼华嗜睡量表（ESS）的影响。我们还使用睡眠问卷功能结局（FOSQ）来评估睡眠结构。我们在两周后使用控制治疗顺序的重复测量模型分析交叉结局指标。
该研究将89名参与者按1:1随机分为（45名）和（44名）两组。一周后，组的AHI反应率为76.7%，组为29.5%，两组之间的差异为47.2%（95%CI：24.4至64.9，<0.001）。同样，组的ESS为7.5±4.9，组为12.0±4.3，两组之间的显著差异为4.6（95%CI：3.1至6.1）。交叉阶段未显示出遗留效应。在完成两个阶段的86名参与者中，组与组在AHI上的治疗差异为-15.5（95%CI -18.3至-12.8），在ESS上为-3.3（95%CI -4.4至-2.2），在FOSQ上为2.1（95%CI 1.4至2.8）。UAS有效治疗了快速眼动（REM）和非快速眼动（NREM）睡眠呼吸紊乱。
与假刺激相比，治疗性UAS降低了中度至重度阻塞性睡眠呼吸暂停参与者的阻塞性睡眠呼吸暂停严重程度、嗜睡症状，并改善了生活质量。
