Yeom Ji Won, Kim Hyojin, Park Soohyun, Yoon Yeaseul, Seo Ju Yeon, Cho Chul-Hyun, Lee Heon-Jeong
Department of Psychiatry, Korea University College of Medicine, Seoul, 02841, Republic of Korea; Chronobiology Institute, Korea University, Seoul, 02841, Republic of Korea.
Department of Psychiatry, Korea University College of Medicine, Seoul, 02841, Republic of Korea; Chronobiology Institute, Korea University, Seoul, 02841, Republic of Korea.
Sleep Med. 2025 May 14;133:106579. doi: 10.1016/j.sleep.2025.106579.
BACKGROUND: Insomnia is a common sleep disorder that significantly impacts quality of life and health. Conventional treatments such as cognitive-behavioral therapy and pharmacological interventions have limitations, underscoring the need for non-invasive alternatives. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising therapy to enhance sleep quality by modulating the autonomic nervous system. OBJECTIVE: This study aimed to evaluate the efficacy and safety of taVNS compared to sham in managing chronic insomnia disorder. METHODS: A randomized, double-blind, sham-controlled trial was conducted with 40 participants diagnosed with chronic insomnia disorder. Participants were randomly assigned to receive taVNS or sham for 30 min daily over six weeks. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) as the primary outcome. Secondary outcomes included the Insomnia Severity Index (ISI), World Health Organization Quality of Life Brief Version (WHOQOL-BREF), and total sleep time. Adverse events were recorded, and objective sleep measures were obtained using Fitbit wearable devices. RESULTS: In the modified intention-to-treat analysis at 6 weeks, the taVNS group exhibited significantly greater reductions in PSQI scores compared to the sham group (mean change: 4.5 ± 3.55 vs. -1.9 ± 2.15; Cohen's d = -1.21; p = .009). ISI scores also improved more in the taVNS group (-7.6 ± 5.23 vs. -4.25 ± 3.48; Cohen's d = -.75; p = .023). Total sleep time increased significantly in the taVNS group (584 ± 1015 min, vs. -10.8 ± 579 min; Cohen's d = .69; p = .019) and improved quality of life (WHOQOL-BREF: 32.2 ± 40.9 vs. 7.95 ± 33.5; Cohen's d = .65, p = .047). No significant adverse events were reported. CONCLUSIONS: taVNS significantly improved sleep quality, insomnia severity, and overall quality of life compared to sham. These findings establish taVNS as a safe and effective non-invasive therapy for managing insomnia, with potential for broader clinical applications.
背景：失眠是一种常见的睡眠障碍，会对生活质量和健康产生重大影响。认知行为疗法和药物干预等传统治疗方法存在局限性，这凸显了对非侵入性替代疗法的需求。经皮耳迷走神经刺激（taVNS）已成为一种有前景的疗法，可通过调节自主神经系统来提高睡眠质量。 目的：本研究旨在评估与假刺激相比，taVNS治疗慢性失眠症的疗效和安全性。 方法：对40名被诊断为慢性失眠症的参与者进行了一项随机、双盲、假刺激对照试验。参与者被随机分配，每天接受taVNS或假刺激30分钟，为期六周。使用匹兹堡睡眠质量指数（PSQI）评估睡眠质量作为主要结局。次要结局包括失眠严重程度指数（ISI）、世界卫生组织生活质量简表（WHOQOL-BREF）和总睡眠时间。记录不良事件，并使用Fitbit可穿戴设备获取客观睡眠指标。 结果：在6周时的改良意向性分析中，与假刺激组相比，taVNS组的PSQI评分显著降低（平均变化：4.5±3.55对-1.9±2.15；Cohen's d=-1.21；p=.009）。taVNS组的ISI评分改善也更多（-7.6±5.23对-4.25±3.48；Cohen's d=-.75；p=.023）。taVNS组的总睡眠时间显著增加（584±1015分钟，对-10.8±579分钟；Cohen's d=.69；p=.019），生活质量得到改善（WHOQOL-BREF：32.2±40.9对7.95±33.5；Cohen's d=.65，p=.047）。未报告重大不良事件。 结论：与假刺激相比，taVNS显著改善了睡眠质量、失眠严重程度和总体生活质量。这些发现确立了taVNS作为一种安全有效的非侵入性失眠治疗方法，具有更广泛临床应用的潜力。
Cochrane Database Syst Rev. 2017-10-9
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