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

NCT07552714 | Not Yet Recruiting

• 1 other identifier: 653/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia, Nonorganic

Keywords

non-organic insomnia; thread embedding acupuncture; auricular acupressure; TCM Syndrome; Interleukin 6; Calprotectin; Gut-brain axis

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline to Week 2, Week 4, and Week 8 (2-week Post-treatment Follow-up)

Secondary Outcomes (4)

• The change in ISI scores

  From Baseline, Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up)

• The change in serum IL-6 levels

  From baseline to week 6 (End of Treatment)

• The change in fecal Calprotectin levels

  From baseline to week 6 (End of Treatment)

• The change in GSRS score

  From From Baseline, Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up)

Study Arms (2)

Standardized Protocol

ACTIVE COMPARATOR

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.

Other: Thread embedding acupuncture; Other: Auricular acupressure

Individualized TCM

EXPERIMENTAL

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 absorbable sutures placed at points tailored to the participant's specific syndrome. * Auricular acupressure using Vaccaria seeds is applied to ear points tailored to the diagnosis 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 .

Other: Thread embedding acupuncture; Other: Auricular acupressure

Interventions

Thread embedding acupuncture OTHER

Thread embedding acupuncture is performed twice at a 4-week interval using the points HT7 (Shenmen), PC6 (Neiguan), SP6 (Sanyinjiao), GB20 (Fengchi), and Anmian.

Standardized Protocol

Auricular acupressure OTHER

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.

Standardized Protocol

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Faculty of Traditional medicine - University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, City, 700000, Vietnam

Location

Related Publications (4)

• 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.

  PMID: 22903446 BACKGROUND

• 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.

  PMID: 36268156 BACKGROUND

• 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.

  PMID: 24159338 BACKGROUND

• 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.

  PMID: 27135191 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Huong TL Le, MD, MSc

CONTACT

+84-983506700; lanhuong@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to treatment group assignment. Study participants will remain unaware of their specific group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized, parallel controlled trial in which study participants, outcome assessors, and data analysts are blinded to the treatment allocation

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

VN (1)