Ancient needle therapy takes on sleepless nights – new study launches

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age: 40 to 75 years. * Cognitive Function: Mini-Mental State Examination (MMSE) score \> 24. * Stable Comorbidities: Participants with hypertension or diabetes must be well-controlled with medication (Blood Pressure \< 140/90 mmHg, HbA1c \< 7%) and have no changes in their medication regimen within the last 3 months. * Modern Medical Criteria: Diagnosis of Chronic Insomnia Disorder according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3). * Sleep Quality Scores: A Pittsburgh Sleep Quality Index (PSQI) score \>= 5 and a total Insomnia Severity Index (ISI) score \>= 10. * TCM Syndrome: Diagnosed with one of the following Traditional Chinese Medicine syndromes: Heart-Spleen Deficiency, Liver Qi Stagnation, or Liver Qi Stagnation with Spleen Deficiency. * Informed Consent: Participants must voluntarily sign the informed consent form and agree to comply with study requirements, including stool sample collection. Exclusion Criteria: * Secondary Insomnia: Sleep disturbances caused by organic conditions (e.g., brain tumor, acute pain, hyperthyroidism, or severe cardiovascular disease). * Gastrointestinal Disorders: Current acute or chronic gastrointestinal diseases (e.g., ulcerative colitis, Crohn's disease, or acute diarrhea). * Specific Medications and Supplements: \* Use of antibiotics, corticosteroids, or Probiotic/Prebiotic supplements within 4 weeks prior to the study. * Use of Proton Pump Inhibitors (PPIs) such as Omeprazole or Esomeprazole within the last 2 weeks. * Regular use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Ibuprofen, Meloxicam, or Diclofenac. * Medical Procedures: Enema or colonoscopy performed within 1 month prior to the study. * Immune Conditions: Autoimmune diseases or rheumatoid arthritis. * Vaccination: Vaccination (e.g., influenza vaccine) within 2 weeks prior to blood collection. * Advanced Chronic Diseases: Late-stage chronic conditions including renal failure (eGFR \< 45), liver failure, or stage III-IV heart failure. * Severe Nocturia: Urinating \>= 3 times per night. * Obstructive Sleep Apnea (OSA): Patients with obesity, loud snoring, and excessive daytime sleepiness. * Pregnancy and Lactation: Women who are pregnant or breastfeeding.