Insomnia, Nonorganic
Conditions
Keywords
non-organic insomnia, thread embedding acupuncture, auricular acupressure, TCM Syndrome, Interleukin 6, Calprotectin, Gut-brain axis
Brief summary
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.
Detailed description
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.
Interventions
Thread embedding acupuncture is performed twice at a 4-week interval using the points HT7 (Shenmen), PC6 (Neiguan), SP6 (Sanyinjiao), GB20 (Fengchi), and Anmian.
OTHERAuricular acupressure
Auricular 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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcome assessors and data analysts will be blinded to treatment group assignment. Study participants will remain unaware of their specific group allocation.
Intervention model description
A randomized, parallel controlled trial in which study participants, outcome assessors, and data analysts are blinded to the treatment allocation
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in PSQI scores | From Baseline to Week 4, and Week 8 (2-week Post-treatment Follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in ISI scores | From Baseline to Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up) | 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 | From baseline to week 6 (End of Treatment) | 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 | From baseline to week 6 (End of Treatment) | 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 | From Baseline to Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up) | 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. |
| Adverse effects | At Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up) | Adverse effects occurring during the treatment and follow-up periods, such as local pain, dizziness, or needle fainting, will be recorded and managed with appropriate measures |
Countries
Vietnam
Contacts
CONTACTHuong TL Le, MD, MSc
Outcome results
None listed