中国医学前沿杂志（电子版）2025，Vol.17Issue(4)：64-68,5.DOI:10.12037/YXQY.2025.04-10
经颅微电流刺激治疗失眠的有效性和安全性:一项随机双盲安慰剂对照试验
Efficacy and safety of cranial electrotherapy stimulation for insomnia:A randomized double-blind placebo-controlled trial
摘要
Abstract
Objective To explore the efficacy and safety of cranial electrotherapy stimulation(CES)in patients with a sleep latency of more than 50 minutes,providing a reference and basis for non-pharmacological treatment of insomnia.Methods This was a double-blind randomized controlled trial.Insomnia patients were recruited from ten communities in Beijing from June 2023 to August 2024.Patients with a sleep onset latency(SOL)of more than 50 minutes,a Pittsburgh Sleep Quality Index(PSQI)score>11,and an Insomnia Severity Index(ISI)score>7 were included.Participants were randomly assigned in a 1︰1 ratio.The experimental group was treated with a CES device daily for 15 minutes over 14 days,while the control group wore an identical device without current stimulation.During the intervention period,patients'sleep parameters,including sleep latency,total sleep time,light sleep duration,deep sleep duration,rapid eye movement(REM)sleep duration,and frequency of awakenings were systematically monitored.PSQI and ISI scores were evaluated on the day 7,day 14 and 4 weeks after the intervention to assess the efficacy of CES treatment.Results A total of 60 patients completed the study,including 18 males and 42 females,with a median age of 38.2 years,a median SOL of 84.7 minutes,PSQI score of 14,and ISI score of 19.After 2 weeks of intervention,the SOL of experimental group decreased by an average of 18.7 min and 2.2 min in control group.There was a statistically significant difference(P<0.05)between the two groups.The PSQI score decreased by 3.4 points in the experimental group and 2.9 points in the control group(P=0.53).The ISI score decreased by 5.6 points in the experimental group and 6.6 points in the control group(P=0.51).No adverse events were reported in the experimental group.Conclusions CES can effectively shorten the sleep onset latency of insomnia patients with high safety,however,there is no significant difference in subjective sleep improvement between the experimental and control group.关键词
失眠/经颅微电流刺激/非药物治疗/睡眠潜伏期/匹兹堡睡眠质量指数量表Key words
Insomnia/Cranial electrotherapy stimulation/Non-pharmacological therapy/Sleep onset latency/Pittsburgh Sleep Quality Index引用本文复制引用
胡汝锐,康琳..经颅微电流刺激治疗失眠的有效性和安全性:一项随机双盲安慰剂对照试验[J].中国医学前沿杂志（电子版）,2025,17(4):64-68,5.基金项目
中央高水平医院临床科研专项(2022-PUMCH-B-129) Central High-level Hospital Clinical Research Project(2022-PUMCH-B-129) （2022-PUMCH-B-129）
