NCT07552714 Individualized TCM Pattern-Based Thread-Embedding Acupuncture Plus Auricular Acupressure for Chronic Insomnia

Eligibility & Interventions

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This trial targets 70 participants in total. It began in 2026-05-18 with a primary completion date of 2027-07-30.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: Age 40 to 75 years. Diagnosis of Chronic Insomnia Disorder according to ICSD-3 criteria. Pittsburgh Sleep Quality Index (PSQI) score ≥5. Insomnia Severity Index (ISI) total score ≥10. Mini-Mental State Examination (MMSE) score \>24. Diagnosis of one of the following prespecified Traditional Chinese Medicine patterns: Heart-Spleen Deficiency; or Liver Qi Stagnation with Spleen Deficiency. TCM pattern diagnosis established according to prespecified standardized diagnostic criteria by a trained TCM practitioner. Participants with hypertension or diabetes may be included if the condition is clinically stable, with no relevant change in medication regimen during the previous 3 months. Able and willing to provide blood and stool samples according to study procedures. Able to understand the study procedures and voluntarily provide written informed consent. Exclusion Criteria Insomnia primarily attributable to another medical, neurological, psychiatric, or sleep disorder requiring alternative management. Current acute or chronic gastrointestinal inflammatory disease, including inflammatory bowel disease, or acute diarrhea. Known Crohn's disease or ulcerative colitis. Use of systemic corticosteroids, antibiotics, probiotics, or prebiotics within 4 weeks before baseline biomarker sampling. Use of proton pump inhibitors within 2 weeks before baseline stool sampling. Regular use of non-steroidal anti-inflammatory drugs. Enema or colonoscopy within 1 month before stool sampling. Active autoimmune or systemic inflammatory disease, including rheumatoid arthritis. Vaccination within 2 weeks before blood sampling. Acute infection or febrile illness at the time of biomarker assessment. Advanced renal, hepatic, or cardiovascular disease, including estimated glomerular filtration rate \<45 mL/min/1.73 m², advanced hepatic failure, or New York Heart Association class III-IV heart failure. Severe nocturia, defined as ≥3 episodes per night. Known obstructive sleep apnea or a high clinical likelihood of obstructive sleep apnea requiring further diagnostic evaluation. Pregnancy or breastfeeding. Any clinical condition considered by the investigators to interfere substantially with sleep assessment, inflammatory biomarker interpretation, treatment safety, or protocol adherence.

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