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, and 8.