Ultrasound-guided stellate ganglion acupuncture for chronic insomnia disorder using fNIRS: study protocol for a...

Chronic insomnia disorder (CID) is common and often impairs daytime functioning and quality of life. Although cognitive behavioral therapy for insomnia and hypnotic medication are widely used, their clinical use may be limited by accessibility, cost, adherence, and concerns about long-term adverse effects. Acupuncture is commonly used for CID, but conventional acupuncture alone may require a relatively long treatment course. Because sympathetic hyperarousal plays an important role in insomnia, the stellate ganglion (SG) may represent a useful therapeutic target. This trial aims to evaluate the clinical efficacy and potential neurofunctional mechanisms of ultrasound-guided SG acupuncture combined with conventional acupuncture in patients with CID.

This single-center, parallel-group randomized controlled trial will enroll 80 patients with CID, who will be allocated in a 1:1 ratio to a treatment group or a control group. In addition, healthy controls will be recruited for baseline functional near-infrared spectroscopy (fNIRS) comparison only. Before fNIRS acquisition, healthy controls will undergo clinical screening and baseline assessments. The control group will receive conventional acupuncture, whereas the treatment group will receive ultrasound-guided SG acupuncture plus conventional acupuncture. Both groups will receive 12 treatment sessions over 4 weeks. Outcomes will be assessed at baseline, week 4, and week 8. The primary outcomes are the Insomnia Severity Index (ISI) and fNIRS data of brain function. Secondary outcomes include the Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Rating Scale (HAMA), and overall clinical efficacy.

This trial will determine whether ultrasound-guided SG acupuncture combined with conventional acupuncture provides additional benefit over conventional acupuncture alone for CID. It will also explore treatment-related changes in brain function by combining clinical scales with fNIRS assessment. The findings may provide more objective evidence for acupuncture-based treatment of CID and help clarify its neurofunctional basis.

https://itmctr.ccebtcm.org.cn/mgt/dashboard, ITMCTR2025000535.