Clinical efficacy of cranial electrotherapy stimulation in chronic insomnia : a research study

Acta Universitatis Medicinalis Anhui 2025, 11, v.60 2144-2153     font:big middle small

Found programs: Open Project of the State Key Laboratory of Cognitive Intelligence ( No . COGOS-2022003 ) ; Natural Science Research Project of Anhui Educational Committee ( No . 2022AH051157 ) ; Scientific Research Project of Anhui Medical University ( No . 2022xkj147 ) ; Health Research Project of Anhui Province ( No . 2024Aa10034 ) ; Joint Research Project of Yangtze River Delta Community of Sci-Tech Innovation ( No . 2024CSJZN00802) ; Special Project for Translational Clinical Medicine Research ( No . 202204295107020024) ; 2022 Second Batch of Online International (Cross-border) Training Pilot Project (No . S222019004)

Authors:Jiao Jiajia , Li Jialu , Sun Xixi , Yin Yunfei , Xie Chengjuan

Keywords:chronic insomnia; cranial electrotherapy stimulation; sleep quality; current frequency; all-night polysomnography;

DOI:10.19405/j.cnki.issn1000-1492.2025.11.021

〔Abstract〕 Objective To investigate the effects of cranial electrotherapy stimulation(CES) with varying parameter configurations on sleep quality in patients diagnosed with chronic insomnia disorder.Methods Seventy-two participants meeting diagnostic criteria for chronic insomnia disorder were randomly allocated to a four-arm parallel study design.The intervention protocol comprised:Group 1(G1) received CES at 0.5 Hz,300 μA;Group 2(G2) underwent CES treatment at 1.5 Hz,300 μA;Group 3(G3) administered 100 Hz,300 μA stimulation;and Group4(G4) received sham stimulation with identical device placement but no current delivery.Primary outcomes were quantified through polysomnography(PSG) recordings conducted at baseline and post-intervention,whereas secondary outcomes were assessed via standardized sleep questionnaires including the Pittsburgh sleep quality index(PSQI) and Insomnia Severity Index(ISI).Results Following a 10-day intervention protocol,significant clinical improvements were observed across all active treatment groups(G1-G3) as evidenced by reductions in PSQI.Insomnia severity index(ISI) scores quantitative polysomnographic analysis revealed that both G2(1.5 Hz) and G3(100 Hz) cohorts demonstrated statistically significant enhancements in Flinders Fatigue Scale(FFS) scores,total sleep time(TST),and sleep efficiency(SE),accompanied by reduced sleep onset latency(SOL) compared to baseline measurements.However,no statistically significant differences were detected between the G2 and G3 intervention arms across all measured parameters.CES exerted no significant effect on sleep architecture.Conclusion CES can effectively improve the sleep of patients with chronic insomnia.Within a certain range,a higher frequency of CES leads to better sleep improvement effects.