Background Although music listening and transcranial direct current stimulation (tDCS) alone have certain effects in the treatment of insomnia, the sleep regulatory effects and neural mechanisms of the combined treatment in patients with insomnia disorder (ID) are unclear. This study aimed to investigate the efficacy of combined bifrontal-tDCS (F3: anode, F4: cathode) with music listening in patients with ID using functional near-infrared spectroscopy (fNIRS). Methods 76 ID patients were randomly divided into an intervention group (n=38) and a control group (n=38), and received 4 weeks of a total of 20 sessions of music + tDCS therapy and music + sham tDCS therapy (30-second stimulation with fade-in/fade-out to mimic somatic sensations), respectively. The Pittsburgh Sleep Quality Index Scale (PSQI), Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Perceived Stress Scale (PSS-14) were compared between the two groups before and after treatment. Oxy-haemoglobin (HbO 2 ) concentration and functional connectivity (FC) were assessed during the verbal fluency task using fNIRS. Results Compared with the control group, the PSQI total score (mean difference: -2.57 points, 95% CI: -4.43 to -0.71, p = 0.001), PSQI sub-scores except “sleep disturbance and daytime dysfunction”, SDS and SAS scores of the intervention group improved significantly after treatment. It was observed by fNIRS that the HbO 2 concentration in the medial prefrontal cortex (mPFC), left dorsolateral prefrontal cortex (DLPFC), right ventrolateral prefrontal cortex, and right superior frontal cortex (SFC) increased significantly after treatment in the intervention group but was not superior to the control group. In addition, the FC enhancement of left SFC-left DLPFC and left SFC-mPFC after treatment was significantly better in the intervention group than in the control group, and the PSQI improvement was positively correlated with the FC enhancement of channel-averaged and left SFC-right DLPFC. Conclusions Combining bifrontal-tDCS with music listening is more helpful in improving sleep quality and prefrontal functional connectivity in ID patients compared with music listening alone. For ID patients, music electrical stimulation headphones may be a safe, effective, and convenient new treatment strategy. Clinical trial registration https://www.chictr.org.cn/ , identifier ChiCTR2400086233.
Shi et al. (Wed,) studied this question.