Thread Embedding Plus Auricular Acupressure for Non-Organic Insomnia Based on Traditional Medicine Pattern Differentiation
Evaluation of the Efficacy of Thread Embedding Acupuncture Combined With Auricular Acupressure Based on Traditional Chinese Medicine Clinical Syndromes in Patients With Non-Organic Insomnia
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huong TL Le, MD, MSc
- Phone Number: +84-983506700
- Email: lanhuong@ump.edu.vn
Study Locations
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City
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Ho Chi Minh City, City, Vietnam, 700000
- Recruiting
- Thong Nhat hospital
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Contact:
- Head of Department
- Phone Number: +84-28 3869 0277
- Email: thongnhathospital@bvtn.org.vn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standardized Protocol
Thread embedding acupuncture performed twice at a 4-week interval using absorbable sutures placed at a fixed set of points for all participants . Auricular acupressure using Vaccaria seeds is applied and replaced every 2 weeks throughout the 8-week study. 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 is performed twice at a 4-week interval using the points HT7 (Shenmen), PC6 (Neiguan), SP6 (Sanyinjiao), GB20 (Fengchi), and Anmian.
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.
Thread 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 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. |
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Experimental: Individualized TCM
Individualized Traditional Chinese Medicine (TCM) syndrome-based therapy tailored to either Heart-Spleen Deficiency or Liver Qi Stagnation:
|
Thread 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 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 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 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change in PSQI scores
Time Frame: From Baseline to Week 4, and Week 8 (2-week Post-treatment Follow-up)
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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.
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From Baseline to Week 4, and Week 8 (2-week Post-treatment Follow-up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The change in serum IL-6 levels
Time Frame: From baseline to week 6 (End of Treatment)
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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.
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From baseline to week 6 (End of Treatment)
|
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The change in fecal Calprotectin levels
Time Frame: From baseline to week 6 (End of Treatment)
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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.
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From baseline to week 6 (End of Treatment)
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The change in ISI scores
Time Frame: From Baseline to Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up)
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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.
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From Baseline to Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up)
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The change in GSRS score
Time Frame: From Baseline to Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up)
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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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From Baseline to Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up)
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Adverse effects
Time Frame: At Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up)
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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
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At Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up)
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Collaborators and Investigators
Publications and helpful links
General Publications
- Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2). doi: 10.7326/P16-9016. Epub 2016 May 3. No abstract available.
- Huo ZJ, Guo J, Li D. Effects of acupuncture with meridian acupoints and three Anmian acupoints on insomnia and related depression and anxiety state. Chin J Integr Med. 2013 Mar;19(3):187-91. doi: 10.1007/s11655-012-1240-6. Epub 2012 Aug 18.
- Zhuang J, Wu J, Fan L, Liang C. Observation on the Clinical Efficacy of Traditional Chinese Medicine Non-Drug Therapy in the Treatment of Insomnia: A Systematic Review and Meta-Analysis Based on Computer Artificial Intelligence System. Comput Intell Neurosci. 2022 Oct 11;2022:1081713. doi: 10.1155/2022/1081713. eCollection 2022.
- Guo J, Wang LP, Liu CZ, Zhang J, Wang GL, Yi JH, Cheng JL. Efficacy of acupuncture for primary insomnia: a randomized controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:163850. doi: 10.1155/2013/163850. Epub 2013 Sep 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 653/ĐHYD-HĐĐĐ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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