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随机、对照交叉试验研究颏舌肌间断和连续经皮电刺激治疗阻塞性睡眠呼吸暂停。

Randomised, controlled crossover trial of intermittent and continuous transcutaneous electrical stimulation of the genioglossus muscle for obstructive sleep apnoea.

机构信息

Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.

Department of Pediatrics, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.

出版信息

Thorax. 2023 Jul;78(7):713-720. doi: 10.1136/thorax-2021-218277. Epub 2022 Sep 7.

DOI:10.1136/thorax-2021-218277
PMID:36690924
Abstract

PURPOSE

Continuous transcutaneous electrical stimulation (CTES) of the genioglossus muscle may benefit patients with obstructive sleep apnoea (OSA). However, the therapeutic value of intermittent transcutaneous electrical stimulation (ITES) for OSA is unclear.

METHODS

This was a randomised, controlled, crossover study to compare the effects of ITES and CTES of the genioglossus muscle. Over three single-night sessions, participants were alternately subjected to three genioglossus stimulation modalities during sleep (sham, CTES and ITES). The apnoea-hypopnoea index (AHI) and oxygen desaturation index (ODI) were used for OSA diagnosis and to evaluate efficacy. A responder was defined as an individual with a ≥50% reduction in AHI together with <10 AHI events per hour and/or an ODI reduction of ≥25% between sham stimulation and electrical stimulation nights.

RESULTS

Fifteen men with OSA completed the study. Compared with sham, the median AHI with ITES decreased by 13.3 events/hour (95% CI 3.1 to 23.5, p=0.030) and by 7.3 events/hour (95% CI -3.9 to 18.5, p=0.825) with CTES. The median ODI was reduced by 9.25 events/hour (95% CI 0.5 to 18.0) with ITES and 3.3 events/hour (95% CI -5.6 to 12.2) with CTES; however, there was no significant difference between groups. Furthermore, ITES outperformed CTES with respect to longest apnoea duration (median (95% CI), 9.5 (0.0 to 19.0), p=0.011)) and the highest sleep efficiency (12.2 (2.7 to 21.7), p=0.009). Of the 15 participants, 8 responded to ITES and 3 responded to CTES (p=0.058), of whom all eight cases and two out of three cases had ODIs <5 events/hour, respectively. All participants tolerated ITES well.

CONCLUSIONS

ITES improved upper airway obstruction in patients with OSA, suggesting that further prospective validation of the intermittent approach is warranted.

TRIAL REGISTRATION NUMBER

ChiCTR2100050138.

摘要

目的

颏舌肌的连续经皮电刺激(CTES)可能有益于阻塞性睡眠呼吸暂停(OSA)患者。然而,间歇经皮电刺激(ITES)治疗 OSA 的治疗价值尚不清楚。

方法

这是一项随机、对照、交叉研究,比较了 ITES 和 CTES 对颏舌肌的影响。在三个单夜的睡眠期间,参与者交替接受三种颏舌肌刺激模式(假刺激、CTES 和 ITES)。呼吸暂停低通气指数(AHI)和氧减指数(ODI)用于 OSA 诊断和评估疗效。应答者定义为 AHI 降低≥50%,同时每小时 AHI 事件数<10 次,或 ODI 降低≥25%,与假刺激和电刺激之夜相比。

结果

15 名 OSA 男性完成了这项研究。与假刺激相比,ITES 时的中位 AHI 降低了 13.3 次/小时(95%CI 3.1 至 23.5,p=0.030),而 CTES 时降低了 7.3 次/小时(95%CI -3.9 至 18.5,p=0.825)。ITES 时的中位 ODI 降低了 9.25 次/小时(95%CI 0.5 至 18.0),CTES 时降低了 3.3 次/小时(95%CI -5.6 至 12.2);然而,组间无显著差异。此外,与 CTES 相比,ITES 在最长呼吸暂停时间(中位数(95%CI),9.5(0.0 至 19.0),p=0.011)和最高睡眠效率(12.2(2.7 至 21.7),p=0.009)方面表现更优。在 15 名参与者中,8 名对 ITES 有反应,3 名对 CTES 有反应(p=0.058),其中所有 8 例和 3 例中的 2 例 ODI<5 次/小时。所有参与者均能耐受 ITES。

结论

ITES 改善了 OSA 患者的上气道阻塞,表明间歇性方法的进一步前瞻性验证是必要的。

试验注册号

ChiCTR2100050138。

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