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一项关于经皮电刺激神经疗法(CES)联合音乐改善睡眠的随机试验。

A randomized trial of CES integrated with music on sleep improvement.

作者信息

Zhang Shengnan, Zhang Huifei, Wei Xinhua, Fang Zibing, Zhang Yuan, Lv Yudan

机构信息

Zhejiang Qiangnao Technology Co., Ltd., Hangzhou, Zhejiang, China.

Department of Neuroscience and Technology Products, Zhejiang Qiangnao Technology Co., Ltd., Hangzhou, Zhejiang, China.

出版信息

BMC Neurol. 2025 Jul 17;25(1):292. doi: 10.1186/s12883-025-04304-3.

Abstract

BACKGROUND

Insomnia population have a number of negative daytime consequences and experience fatigue and irritability. CES or Music has been reported as a self-help tool to improve insomnia with few data support. Thus, a systematic randomized controlled trial study is needed to establish the efficacy of CES integrated with music for insomnia as an alternative strategy.

METHODS

Study is based on a quasi-random process. All participants have been divided into three such as control group with treatment-as-usual (TAU) alone, CES plus double beat added to TAU, CES plus Pink noise added to TAU. Sleep onset latency (SoL), Total sleep time (TST), Proportion of deep sleep and Sleep quality have been analyzed.

RESULTS

A significant effect of CES plus music on improvement of SL and quality of life (QoL) has been found, but no effect on TST and proportion of deep sleep. Age group from 20 to 29 years shows better adaptability and recoverability to the intervention.

CONCLUSIONS

Our study shows a significant effect of CES plus music on perceived sleep improvement and quality of life with safety. Future studies should explore that whether CES plus music could be applied as an adjuvant or preventive strategy to standard treatment for persons with insomnia or subtypes.

TRIAL REGISTRATION

Registration number: ChiCTR2300073223. Trial registration date: 4 July 2023. Retrospectively registered.

摘要

背景

失眠人群在白天会出现诸多负面后果,如疲劳和易怒。经颅电刺激(CES)或音乐已被报道为改善失眠的自助工具,但相关数据支持较少。因此,需要进行一项系统的随机对照试验研究,以确定将CES与音乐结合用于治疗失眠作为一种替代策略的疗效。

方法

本研究基于准随机过程。所有参与者被分为三组,即仅采用常规治疗(TAU)的对照组、在TAU基础上加用CES和双节拍的组、在TAU基础上加用CES和粉红噪声的组。分析了入睡潜伏期(SoL)、总睡眠时间(TST)、深度睡眠比例和睡眠质量。

结果

发现CES加音乐对改善入睡潜伏期和生活质量(QoL)有显著效果,但对总睡眠时间和深度睡眠比例没有影响。20至29岁年龄组对干预的适应性和恢复能力更好。

结论

我们的研究表明,CES加音乐对改善睡眠感知和生活质量有显著效果且安全。未来的研究应探索CES加音乐是否可作为失眠患者或亚型标准治疗的辅助或预防策略。

试验注册

注册号:ChiCTR2300073223。试验注册日期:2023年7月4日。回顾性注册。

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