School of Health Science, Guangdong Pharmaceutical University, Guangzhou, 51000, China.
Guangdong Provincial Engineering and Technology Research Center of Light and Health, Guangzhou, 51000, China.
BMC Complement Med Ther. 2023 Nov 8;23(1):401. doi: 10.1186/s12906-023-04242-y.
Insomnia is a prevalent sleep disorder that affects up to 15% of the population worldwide and is the second most common mental health issue. There is increasing interest in the effects of long-term insomnia on cognitive function. Electroacupuncture can effectively improve cognitive function and sleep quality, yet the underlying brain network mechanisms remain unclear. This study aims to explore the network regulatory mechanisms associated with enhanced cognitive function and sleep quality, providing theoretical support for the use of electroacupuncture in the clinical treatment of chronic insomnia.
This study is divided into two parts. Sixteen individuals with chronic insomnia and 16 healthy controls of similar age and gender will be recruited in Study 1 to examine the brain network topology of individuals with chronic insomnia. Study 2 will be a randomized controlled trial with 120 chronic insomnia patients divided into three groups: Group A (electroacupuncture plus placebo drug), Group B (drug plus placebo electroacupuncture), and Group C (placebo electroacupuncture plus placebo drug). Participants will be exposed to 24 treatments over an 8-week period (3 times per week) and monitored for 12 additional weeks. The primary outcome measure will be changes in brainwave data from before to after the treatment. In addition, the Wisconsin Card Sorting Test and the Pittsburgh Sleep Quality Index will be utilized as secondary outcomes to measure from before to after treatment and during the follow-up. A correlation analysis will be conducted to explore links among modifications in brainwave patterns, Wisconsin Card Sorting Test scores, and Pittsburgh Sleep Quality Index scores. Additionally, any adverse events will be strictly monitored.
Electroacupuncture may represent an alternative treatment for chronic insomnia, and this trial is expected to reveal the brain mechanism by which electroacupuncture improves cognitive function and sleep quality in chronic insomnia patients.
ChiCTR2200060150 (Chinese Clinical Trial Registry, http://www.chictr.org.cn , registered on 20 May 2022).
失眠是一种普遍的睡眠障碍，全球有多达 15%的人口受其影响，是第二大常见的心理健康问题。人们越来越关注长期失眠对认知功能的影响。电针可以有效改善认知功能和睡眠质量，但潜在的大脑网络机制尚不清楚。本研究旨在探讨与增强认知功能和睡眠质量相关的网络调节机制，为电针在慢性失眠的临床治疗中的应用提供理论支持。
本研究分为两部分。研究 1 将招募 16 名慢性失眠患者和 16 名年龄和性别相匹配的健康对照者，以检查慢性失眠患者的大脑网络拓扑结构。研究 2 将是一项随机对照试验，共纳入 120 名慢性失眠患者，分为三组：A 组（电针加安慰剂药物）、B 组（药物加安慰剂电针）和 C 组（安慰剂电针加安慰剂药物）。参与者将接受 24 次治疗，为期 8 周（每周 3 次），并监测 12 周。主要结局指标是治疗前后脑电波数据的变化。此外，威斯康星卡片分类测验和匹兹堡睡眠质量指数将作为次要结局指标，用于治疗前后和随访期间的测量。将进行相关性分析，以探讨脑电波模式变化、威斯康星卡片分类测验评分和匹兹堡睡眠质量指数评分之间的联系。此外，将严格监测任何不良事件。
电针可能是慢性失眠的一种替代治疗方法，本试验预计将揭示电针对慢性失眠患者认知功能和睡眠质量改善的大脑机制。
ChiCTR2200060150（中国临床试验注册中心，http://www.chictr.org.cn ，注册于 2022 年 5 月 20 日）。
