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Ultrasound-guided stellate ganglion acupuncture for chronic insomnia disorder using fNIRS: study protocol for a randomized controlled trial
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DOI：10.3389/fneur.2026.1855633.png)
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Abstract
En 中文
BackgroundChronic 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/designThis 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.DiscussionThis 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 registrationhttps://itmctr.ccebtcm.org.cn/mgt/dashboard; ITMCTR2025000535.
Keywords:
acupuncture
insomnia
ultrasound
functional near-infrared spectroscopy
randomized controlled trial
brain function
stellate ganglion
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