Table 4.
Electrical stimulation therapies for insomnia.
| Therapy | Evaluation item | Evaluation results | |||||||
|---|---|---|---|---|---|---|---|---|---|
| tES (tACS/tDCS) |
Representative Study Design | Literature | Population | N | RCT | Placebo effect excluded | Objective biomarkers | Follow-up | |
| (130) | (b) adults with sleep-onset insomnia symptoms | 24 | Yes | Partly yes | Yes | No | |||
| (131) | (a) diagnosed by DSM-5 | 54 | Yes | No | No | Yes | |||
| (174) | (a) diagnosed by ICD-11 | 157 | Yes | No | No | Yes | |||
| Main Clinical Findings & Safety | Mixed but partly positive sleep effects; may improve PSQI, SE, TST, or SOL. Mostly tolerable, but one high-current study raised safety concerns (133). | ||||||||
| Limitations | Small samples; heterogeneous protocols; limited objective data/follow-up; sham/blinding and reporting issues. | ||||||||
| Evidence Level | Emerging. Promising but inconsistent evidence; insufficient for routine clinical use. | ||||||||
| taVNS | Representative Study Design | Literature | Population | N | RCT | Placebo effect excluded | Objective biomarkers | Follow-up | |
| (134) | (a) diagnosed by DSM-5 | 72 | Yes | Yes | No | Yes | |||
| (135) | (a) diagnosed by ICSD-3 | 40 | Yes | Yes | Yes | No | |||
| (143) | (a) diagnosed by DSM-5 | 67 | Yes | Yes | No | No | |||
| Main Clinical Findings & Safety | taVNS improved sleep quality/insomnia severity and some sleep parameters; adverse events were rare, mild, and manageable (132, 144). | ||||||||
| Limitations | Small samples, heterogeneous protocols, short follow-up, mostly subjective outcomes, and bias concerns. | ||||||||
| Evidence Level | Emerging. Benefits are suggested, but certainty remains low/very low; larger sham-controlled RCTs are needed. | ||||||||
| Neurofeedback Biofeedback |
Representative Study Design | Literature | Population | N | RCT | Placebo effect excluded | Objective biomarkers | Follow-up | |
| (136) | (a) diagnosed by DSM-4 | 82 | No | No | Yes | No | |||
| (137) | (a) diagnosed by DSM-5 | 17 | Yes | No | Yes | Yes | |||
| (138) | (c) cancer patients | 28 | Yes | No | Yes | No | |||
| Main Clinical Findings & Safety | Possible sleep benefits in small studies, but surface neurofeedback did not outperform controls for insomnia/sleep quality (139). Stress biofeedback improved stress/anxiety/depression (140). No major safety concerns reported. | ||||||||
| Limitations | Small samples, heterogeneous protocols, limited sham controls, mostly self-report, short/unclear follow-up, indirect populations. | ||||||||
| Evidence Level | Emerging. Some supportive controlled/meta-analytic data, but insomnia-specific efficacy is inconsistent and limited by bias, heterogeneity, and weak long-term evidence. | ||||||||
| HVET | Representative Study Design | Literature | Population | N | RCT | Placebo effect excluded | Objective biomarkers | Follow-up | |
| (148) | (b) adults | 100 | No | No | No | No | |||
| (149) | (b) adults | 40 | No | No | No | No | |||
| (150) | (a) Chinese Guidelines for the Diagnosis and Treatment of Adult Insomnia, 2017 edition | 88 | Yes | No | No | No | |||
| Main Clinical Findings & Safety | Studies suggest improved PSQI/sleep quality; one add-on RCT also reported fewer adverse events. No major safety issues reported. | ||||||||
| Limitations | Small, short-term; limited randomization; no sham control; subjective outcomes only; no follow-up. | ||||||||
| Evidence Level | Exploratory. Evidence is mainly small/limited clinical data without adequate controlled validation. | ||||||||