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电前庭刺激(VeNS)对失眠成年人的疗效:一项双盲、随机、假对照试验。

Efficacy of electrical vestibular stimulation (VeNS) on adults with insomnia: A double-blind, randomized, sham-controlled trial.

作者信息

Cheung Teris, Lam Joyce Yuen Ting, Fong Kwan Hin, Cheng Calvin Pak-Wing, Xiang Yu-Tao, Li Tim Man Ho

机构信息

School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR, China.

The Mental Health Research Centre, The Hong Kong Polytechnic University, Hong Kong SAR, China.

出版信息

Dialogues Clin Neurosci. 2025 Dec;27(1):236-248. doi: 10.1080/19585969.2025.2526547. Epub 2025 Jul 11.

Abstract

INTRODUCTION

Insomnia, a widespread sleep disorder, affects a significant portion of the global population. This study is the first in Asia to evaluate the efficacy of electrical vestibular stimulation (VeNS) as a treatment for insomnia in Hong Kong adults, addressing a gap in non-pharmacological interventions.

METHODS

A double-blind, randomized, sham-controlled trial was conducted with 101 adults exhibiting insomnia symptoms. Participants were randomized into active VeNS or sham groups (1:1 ratio) and underwent twenty 30-minute VeNS sessions over four weeks. Psychological outcomes, including insomnia severity, sleep quality, and quality of life were assessed at baseline (T1), post-intervention (T2). Follow-up assessments were conducted at one- (T3) and three-month (T4) to evaluate the sustainability of VeNS effects.

RESULTS

Of 83 participants (40 VeNS and 43 sham-VeNS), the VeNS group showed significant reductions in insomnia severity at T2 (p = 0.03, d = -0.47) and T4 (p = 0.02, d = -0.32), alongside improved quality of life (i.e., role-physical) at T2.

CONCLUSION

VeNS is a novel, non-invasive and safe neuromodulation device that may serve as an adjunct treatment for primary insomnia. The present findings provide a foundation for future multisite comparison studies to further evaluate VeNS efficacy.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04452981.

摘要

引言

失眠是一种普遍存在的睡眠障碍,影响着全球相当一部分人口。本研究是亚洲首个评估电前庭刺激(VeNS)对香港成年人失眠治疗效果的研究,填补了非药物干预方面的空白。

方法

对101名有失眠症状的成年人进行了一项双盲、随机、假对照试验。参与者被随机分为主动VeNS组或假刺激组(1:1比例),并在四周内接受20次每次30分钟的VeNS治疗。在基线(T1)、干预后(T2)评估心理结果,包括失眠严重程度、睡眠质量和生活质量。在1个月(T3)和3个月(T4)进行随访评估,以评估VeNS效果的可持续性。

结果

在83名参与者(40名VeNS组和43名假VeNS组)中,VeNS组在T2(p = 0.03,d = -0.47)和T4(p = 0.02,d = -0.32)时失眠严重程度显著降低,同时在T2时生活质量(即身体角色)有所改善。

结论

VeNS是一种新型、非侵入性且安全的神经调节设备,可作为原发性失眠的辅助治疗方法。目前的研究结果为未来多中心比较研究进一步评估VeNS的疗效奠定了基础。

试验注册

ClinicalTrials.gov标识符:NCT04452981。

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