Non-organic insomnia is a prevalent disorder that significantly impairs quality of life, characterized by difficulty initiating or maintaining sleep alongside daytime functional decline. This condition is particularly common among adults facing chronic stress, which increases the risk of chronic diseases and dysregulates the Microbiota-Gut-Brain Axis (MGBA)-a bidirectional communication system between the central nervous system and the gut microbiota. Prolonged sleep deprivation and stress can trigger inflammatory responses and gut dysbiosis, which in turn exacerbate emotional and sleep disturbances. While conventional sedative-hypnotics often carry side effects and risks of dependency, traditional medicine interventions are emerging as potential sustainable solutions. This study evaluates the efficacy of thread embedding combined with auricular acupressure based on individualized traditional Chinese medicine syndrome differentiation, while clarifying the relationship between clinical sleep improvement and changes in MGBA-related inflammatory markers, specifically interleukin-6 and calprotectin.
The goal of this clinical trial is to evaluate the clinical efficacy and preliminarily investigate the mechanisms of action-via the Microbiota-Gut-Brain Axis-of individualized Traditional Chinese Medicine (targeting Heart-Spleen Deficiency and Liver Qi Stagnation syndromes) using thread embedding acupuncture combined with auricular acupressure to improve sleep quality in patients with insomnia, compared to a non-individualized protocol. The main questions it aims to answer are:
* Does the combined method of thread embedding acupuncture and auricular acupressure based on syndrome differentiation improve sleep quality more effectively than the standardized protocol? * Is there a significant difference in the change of IL-6 and Calprotectin levels following treatment in the intervention group compared to the control group? * Does post-treatment clinical improvement correlate with the reduction of these inflammatory markers?
Participants will:
* Receive thread embedding acupuncture sessions every 4 weeks and have ear seeds (auricular acupressure) replaced every 2 weeks . Self-massage the ear seeds for 1 to 2 minutes several times each day, especially before bedtime. * Complete assessments of sleep quality (PSQI, ISI) and digestive health (GSRS) every 2 weeks through week 8. * Provide blood and stool samples at the start and end of the study to measure inflammation markers. * Be monitored for any adverse effects, such as local pain, dizziness, or needle fainting, during the trial period.
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).
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.
Parallel
Thread embedding acupuncture
Other interventionThread embedding acupuncture is performed twice at a 4-week interval using the points HT7 (Shenmen), PC6 (Neiguan), SP6 (Sanyinjiao), GB20 (Fengchi), and Anmian.
Auricular acupressure
Other interventionAuricular acupressure using Vaccaria seeds is applied and replaced every 2 weeks on the points Shenmen (TF4), Subcortex, Occiput, Forehead, Kidney, and Endocrine. Participants are instructed to perform self-massage on the ear seeds 3-5 times daily for 1-2 minutes per point, particularly 30 minutes before bedtime.
Thread embedding acupuncture
Other interventionThread embedding acupuncture is performed twice at a 4-week interval using absorbable sutures. The selection of acupoints is strictly tailored to the participant's Traditional Chinese Medicine (TCM) syndrome differentiation: Heart-Spleen Deficiency: The procedure utilizes the points BL15 (Xinshu), BL20 (Pishu), ST36 (Zusanli), SP6 (Sanyinjiao), and ST25 (Tianshu). Liver Qi Stagnation: The procedure utilizes the points BL18 (Ganshu), LR3 (Taichong), GB34 (Yanglingquan), SP6 (Sanyinjiao), and PC6 (Neiguan).
Auricular acupressure
Other interventionAuricular acupressure using Vaccaria seeds (ear seeds) is applied to reflex points on the ear and replaced every 2 weeks throughout the 8-week study period. The selection of ear points is customized based on the TCM syndrome. Heart-Spleen Deficiency: The points include Heart (CO15), Spleen (CO13), Stomach (CO4), TF4 (Shenmen), and Subcortex (AT4). Liver Qi Stagnation: The points include Liver (CO12), Gallbladder (CO11), Sympathetic (AH6a), TF4 (Shenmen), and Subcortex (AT4). Participants are instructed to perform self-massage on the ear seeds for 1-2 minutes per point, 3-5 times daily, particularly 30 minutes before bedtime.
The change in PSQI scores
This is a quantitative variable measured in scores. The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated items grouped into seven components. Each component is scored from 0 to 3, resulting in a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
The change in ISI scores
This is a quantitative variable measured in scores. The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the severity of insomnia symptoms. Each item is rated on a 5-point Likert scale (0-4), with a total score ranging from 0 to 28. Higher scores represent greater insomnia severity.
The change in serum IL-6 levels
This is a quantitative variable measured in pg/mL. Serum Interleukin-6 (IL-6) levels are measured via laboratory analysis to evaluate systemic inflammatory responses associated with the Microbiota-Gut-Brain Axis.
The change in fecal Calprotectin levels
This is a quantitative variable measured in μg/g. Fecal calprotectin is used as a biochemical marker of intestinal inflammation to assess changes in gut health during the trial.
The change in GSRS score
A quantitative variable assessing gut health via the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire (15 items, 5 clusters: abdominal pain, reflux, indigestion, diarrhea, and constipation). Items are rated on a 7-point Likert scale (1: "No symptoms" to 7: "Very severe"). Higher total scores indicate greater gastrointestinal dysfunction.
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