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.

失眠障碍已成为全球性公共卫生难题，常与焦虑、抑郁共病，现有疗法各有局限。星状神经节阻滞（SGB）联合失眠认知行为疗法（CBT-I）展现出潜力，但联合方案中SGB的最佳治疗频率尚不明确。

比较高频（连续12 d）与低频（连续6 d）SGB联合CBT-I治疗失眠障碍的疗效与安全性。

本研究为一项前瞻性、随机对照试验，选取2025年2—8月在广州中医药大学第三附属医院麻醉睡眠门诊就诊的失眠障碍患者126例，随机分为高频SGB组（HF-SGB组，n=63）与低频SGB组（LF-SGB组，n=63）。两组患者均接受为期4周的标准CBT-I；在此基础上，HF-SGB组接受连续12 d、LF-SGB组接受连续6 d的超声引导下SGB治疗。于疗程开始前1 d（基线，T1）、疗程结束后1 d（T2）、疗程结束后4周（T3）及疗程结束后12周（T4）采用匹兹堡睡眠质量指数（PSQI）、广泛性焦虑障碍量表（GAD-7）、患者健康问卷（PHQ-9）进行评估，并记录治疗过程中的不良反应发生情况。

共116例患者完成随访，HF-SGB组和LF-SGB组各58例。重复测量方差分析结果显示，PSQI、GAD-7、PHQ-9得分的时间主效应、组别主效应及交互效应均有统计学意义（P<0.05）。除LF-SGB组在T4时间点的PHQ-9得分与基线比较，差异无统计学意义（P>0.05）外，两组其余各项得分在T2、T3、T4时间点较基线降低（P<0.05）。在T2、T3、T4时间点，HF-SGB组的PSQI、GAD-7、PHQ-9得分均低于LF-SGB组（P<0.05）；在T2时间点，两组PSQI得分中位数相差3分，达到该量表的最小临床重要差异（MCID）。两组不良反应发生率比较，差异无统计学意义（P>0.05），且均为轻度、一过性。

高频SGB联合CBT-I在改善失眠障碍患者的睡眠及情绪症状方面，疗效优于低频方案，且安全性与低频方案相当，提示连续12 d的SGB疗程可作为更优的临床选择。