Individualized TCM Pattern-Based Thread-Embedding Acupuncture Plus Auricular Acupressure for Chronic Insomnia

Chronic insomnia disorder is a common sleep disorder associated with impaired daytime functioning and may be accompanied by alterations in immune-inflammatory and gut-related biological processes. Traditional Chinese medicine (TCM) uses pattern differentiation to individualize treatment; however, the additional clinical value of pattern-based treatment compared with a standardized protocol remains insufficiently established. This randomized controlled trial will evaluate whether individualized TCM pattern-based thread-embedding acupuncture combined with auricular acupressure improves sleep quality more effectively than the same therapeutic modalities delivered using a standardized fixed-point protocol in adults with chronic insomnia disorder. Participants will be classified as having either Heart-Spleen Deficiency or Liver Qi Stagnation with Spleen Deficiency according to prespecified TCM diagnostic criteria and randomized 1:1 to individualized pattern-based treatment or standardized treatment. The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to the end of treatment. Secondary clinical outcomes include insomnia severity measured by the Insomnia Severity Index (ISI), gastrointestinal symptoms measured by the Gastrointestinal Symptom Rating Scale (GSRS), and adverse events. Serum interleukin-6 (IL-6) and fecal calprotectin will be assessed as exploratory systemic and gut-related inflammatory biomarkers. These biomarkers are intended to explore biological correlates potentially relevant to gut-brain interactions and are not considered diagnostic markers of insomnia or direct measures of the microbiota-gut-brain axis. Clinical outcomes will additionally be assessed at Week 10, four weeks after completion of scheduled treatment, to evaluate persistence of clinical effects.