Effect of Transcranial Alternating Current Stimulation for the Treatment of Chronic Insomnia: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Clinical Trial
Effect of Transcranial Alternating Current Stimulation for the Treatment of Chronic Insomnia: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Clinical Trial
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经颅交流电刺激治疗慢性失眠的效果：随机、双盲、平行组、安慰剂对照临床试验
DOI：
10.1159/000504609
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发表时间：
2020-01-01
影响因子：
22.8
通讯作者：
Wang, Yu-Ping
中科院分区：
文献类型：
--
作者：
Wang, Hong-Xing;Wang, Li;Wang, Yu-Ping
背景资料：并非所有患有慢性失眠症的成年人都对推荐的认知行为疗法和批准的催眠药物有反应。经颅交流电刺激（tACS）可能为失眠症提供一种新的潜在治疗方式。目的：本研究旨在检查tACS治疗成人慢性失眠患者的有效性和安全性。研究方法：62名患有慢性原发性失眠症的参与者在工作日连续4周在实验室接受20次每天40分钟，77.5 Hz，15 mA的主动或假tACS治疗，目标是前额和两个乳突区域，随后是4周的随访期。主要结果是在第8周通过匹兹堡睡眠质量指数（PSQI）测量的应答率。次要结局是缓解率、失眠严重程度、睡眠开始潜伏期（SOL）、总睡眠时间（TST）、睡眠效率、睡眠质量、日常干扰以及4周干预结束时和4周随访时的不良事件。结果：在62例随机化患者中，60例完成了试验。在为期4周的干预期间，每组各有1例受试者因兴趣丧失和时间限制退出。基于PSQI，在4周随访时，活性组的缓解率高于假手术组（53.4% [16/30] vs. 16.7% [5/30]，p = 0.009），但两组的缓解率无差异。在4周干预结束时，活性组的反应率和缓解率高于假手术组（分别为p < 0.001和p = 0.026）。在试验期间，与假手术组相比，活性组显示PSQI总分统计学显著降低，SOL缩短，TST增加，睡眠效率改善，睡眠质量改善（p < 0.05或p < 0.001）。事后分析显示，与假手术组相比，活性组在4周干预结束时症状改善，除日常干扰外，在4周随访时所有症状均显著改善。研究期间未发生不良事件或严重不良反应。结论：研究结果表明，在本研究中应用的tACS有潜力作为一个有效和安全的干预慢性失眠8周内。
Background: Not all adults with chronic insomnia respond to the recommended therapeutic options of cognitive behavioral therapy and approved hypnotic drugs. Transcranial alternating current stimulation (tACS) may offer a novel potential treatment modality for insomnia. Objectives: This study aimed to examine the efficacy and safety of tACS for treating adult patients with chronic insomnia. Methods: Sixty-two participants with chronic primary insomnia received 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas in the laboratory on weekdays for 4 consecutive weeks, followed by a 4-week follow-up period. The primary outcome was response rate measured by the Pittsburgh Sleep Quality Index (PSQI) at week 8. Secondary outcomes were remission rate, insomnia severity, sleep onset latency (SOL), total sleep time (TST), sleep efficiency, sleep quality, daily disturbances, and adverse events at the end of the 4-week intervention and at the 4-week follow-up. Results: Of 62 randomized patients, 60 completed the trial. During the 4-week intervention, 1 subject per group withdrew due to loss of interest and time restriction, respectively. Based on PSQI, at 4-week follow-up, the active group had a higher response rate compared to the sham group (53.4% [16/30] vs. 16.7% [5/30], p = 0.009), but remission rates were not different between groups. At the end of the 4-week intervention, the active group had higher response and remission rates than the sham group (p < 0.001 and p = 0.026, respectively). During the trial, compared with the sham group, the active group showed a statistically significant decrease in PSQI total score, a shortened SOL, an increased TST, improved sleep efficiency, and improved sleep quality (p < 0.05 or p < 0.001). Post hoc analysis revealed that, in comparison with the sham group, the active group had improved symptoms, except for daily disturbances, at the end of the 4-week intervention, and significant improvements in all symptoms at the 4-week follow-up. No adverse events or serious adverse responses occurred during the study. Conclusion: The findings show that the tACS applied in the present study has potential as an effective and safe intervention for chronic insomnia within 8 weeks.