Key result
This study protocol describes a randomized controlled trial designed to evaluate whether adding ultrasound-guided stellate ganglion acupuncture to conventional acupuncture improves chronic insomnia; no results are available yet.
Why the study?
Conventional treatments for chronic insomnia disorder face limitations, and conventional acupuncture alone often requires a long treatment course, prompting evaluation of the stellate ganglion as a therapeutic target.
RCT (n=80)
Single-blind
1:1
No
Should not yet change practice; leaves open whether adding ultrasound-guided SG acupuncture shortens course or improves ISI over conventional acupuncture.
Background: 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. Methods/design: 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. Discussion: 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. Clinical trial registration: https://itmctr.ccebtcm.org.cn/mgt/dashboard, ITMCTR2025000535.
No takes yet. Share an insight, caveat, or question.
Zhang et al. (2026) conducted an RCT in Chronic insomnia disorder (n=80). Ultrasound-guided stellate ganglion acupuncture plus conventional acupuncture vs. Conventional acupuncture alone was evaluated on Change in Insomnia Severity Index (ISI) score and task-evoked prefrontal oxygenated hemoglobin response measured by fNIRS from baseline to week 4. This study protocol describes a randomized controlled trial designed to evaluate whether adding ultrasound-guided stellate ganglion acupuncture to conventional acupuncture improves chronic insomnia; no results are available yet.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: