Thread Embedding Plus Auricular Acupressure for Non-Organic Insomnia Based on Traditional Medicine Pattern Differentiation

Participants and Methods: A randomized, single-blind, controlled trial will be conducted with 70 participants, aged 40 to 75 years, residing in Ho Chi Minh City, who exhibit symptoms of chronic non-organic insomnia based on ICSD-3 criteria. Participants were required to meet the inclusion criteria and not fall under any exclusion criteria.

Randomization and Grouping: Participants will be randomly assigned into two groups in a 1:1 ratio using a permuted variable block randomization method. The intervention group will receive individualized Traditional Chinese Medicine (TCM) syndrome-based therapy. This involves thread embedding acupuncture using absorbable sutures and auricular acupressure using Vaccaria seeds applied to specific points tailored to either Heart-Spleen Deficiency or Liver Qi Stagnation syndromes. The control group will receive a standardized protocol using the same methods but with a fixed set of acupoints regardless of TCM syndrome.

Procedure and Assessments: Both groups will be provided with instructions on how to self-massage the auricular seeds for 1-2 minutes, 3-5 times daily, particularly 30 minutes before bedtime. The intervention will last for 8 weeks, with thread embedding acupuncture performed twice at 4-week intervals and auricular seeds replaced every 2 weeks. Clinical outcomes will be assessed using the PSQI, ISI, and Gastrointestinal Symptom Rating Scale (GSRS). To investigate the Microbiota-Gut-Brain Axis (MGBA) mechanisms, laboratory data including serum interleukin-6 (IL-6) and fecal calprotectin will be collected at baseline and after 8 weeks. Adverse effects, such as local pain, dizziness, or needle fainting, will be carefully monitored and recorded at week 2, 4, 6 and 8.

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.