Insomnia disorder has become a global public health challenge, frequently comorbid with anxiety and depression, while existing monotherapies have their respective limitations. The combination of stellate ganglion block (SGB) and cognitive behavioral therapy for insomnia (CBT-I) shows promise, but the optimal treatment frequency of SGB within this combined regimen remains unclear.

This study aimed to directly compare the efficacy and safety of high-frequency (12 consecutive days) versus low-frequency (6 consecutive days) SGB combined with CBT-I in the treatment of insomnia disorder.

This study was a prospective randomized controlled trial. A total of 126 patients with insomnia disorder who attended the Anesthesia Sleep Clinic of the Third Affiliated Hospital of Guangzhou University of Chinese Medicine from February to August 2025 were enrolled and randomly divided into a high-frequency SGB group (HF-SGB group, n=63) and a low-frequency SGB group (LF-SGB group, n=63). All patients received standard CBT-I for 4 weeks. On this basis, the HF-SGB group underwent ultrasound-guided SGB treatment for 12 consecutive days, while the LF-SGB group received SGB for 6 consecutive days. Assessments were conducted using the Pittsburgh Sleep Quality Index (PSQI), the Generalized Anxiety Disorder scale (GAD-7), and the Patient Health Questionnaire (PHQ-9) at one day before treatment initiation (baseline, T1), one day after treatment completion (T2), 4 weeks after treatment completion (T3), and 12 weeks after treatment completion (T4). Adverse events during treatment were also recorded.

A total of 116 patients completed the follow-up, with 58 in each group. Repeated-measures ANOVA showed that the main effects of time, the main effects of group, and the time×group interaction effects for PSQI, GAD-7, and PHQ-9 scores were all statistically significant (P<0.05). Except for the PHQ-9 score in the LF-SGB group at T4, which showed no statistically significant difference compared to baseline (P>0.05), all other scores in both groups improved from baseline at T2, T3, and T4 (P<0.05). At all follow-up time points, the PSQI, GAD-7, and PHQ-9 scores in the HF-SGB group were significantly lower than those in the LF-SGB group (P<0.05). At T2, the median PSQI score difference between the two groups was 3 points, reaching the minimal clinically important difference for this scale. There was no statistically significant difference in the incidence of adverse events between the two groups (P>0.05), and all adverse events were mild and transient.

High-frequency SGB combined with CBT-I is superior to the low-frequency regimen in improving sleep and emotional symptoms in patients with insomnia disorder, with comparable safety. The 12-day SGB protocol can be considered the preferred clinical option.