RECRUITING Not applicable ClinicalTrials.gov

Individualized TCM Pattern-Based Thread-Embedding Acupuncture Plus Auricular Acupressure for Chronic Insomnia

Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City • ClinicalTrials.gov ID: NCT07552714

Registry updated: 2026-09-25

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

Chronic insomnia disorder is a common sleep disorder associated with impaired daytime functioning and may be accompanied by alterations in immune-inflammatory and gut-related biological processes. Traditional Chinese medicine (TCM) uses pattern differentiation to individualize treatment; however, the additional clinical value of pattern-based treatment compared with a standardized protocol remains insufficiently established. This randomized controlled trial will evaluate whether individualized TCM pattern-based thread-embedding acupuncture combined with auricular acupressure improves sleep quality more effectively than the same therapeutic modalities delivered using a standardized fixed-point protocol in adults with chronic insomnia disorder. Participants will be classified as having either Heart-Spleen Deficiency or Liver Qi Stagnation with Spleen Deficiency according to prespecified TCM diagnostic criteria and randomized 1:1 to individualized pattern-based treatment or standardized treatment. The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to the end of treatment. Secondary clinical outcomes include insomnia severity measured by the Insomnia Severity Index (ISI), gastrointestinal symptoms measured by the Gastrointestinal Symptom Rating Scale (GSRS), and adverse events. Serum interleukin-6 (IL-6) and fecal calprotectin will be assessed as exploratory systemic and gut-related inflammatory biomarkers. These biomarkers are intended to explore biological correlates potentially relevant to gut-brain interactions and are not considered diagnostic markers of insomnia or direct measures of the microbiota-gut-brain axis. Clinical outcomes will additionally be assessed at Week 10, four weeks after completion of scheduled treatment, to evaluate persistence of clinical effects.

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.
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.
Thread embedding acupuncture (Other)
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 with Spleen Deficiency: The procedure utilizes the points BL18 (Ganshu), LR3 (Taichong), GB34 (Yanglingquan), SP6 (Sanyinjiao), and PC6 (Neiguan).
Auricular acupressure (Other)
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.

Eligibility criteria

Inclusion Criteria: Age 40 to 75 years. Diagnosis of Chronic Insomnia Disorder according to ICSD-3 criteria. Pittsburgh Sleep Quality Index (PSQI) score ≥5. Insomnia Severity Index (ISI) total score ≥10. Mini-Mental State Examination (MMSE) score \>24. Diagnosis of one of the following prespecified Traditional Chinese Medicine patterns: Heart-Spleen Deficiency; or Liver Qi Stagnation with Spleen Deficiency. TCM pattern diagnosis established according to prespecified standardized diagnostic criteria by a trained TCM practitioner. Participants with hypertension or diabetes may be included if the condition is clinically stable, with no relevant change in medication regimen during the previous 3 months. Able and willing to provide blood and stool samples according to study procedures. Able to understand the study procedures and voluntarily provide written informed consent. Exclusion Criteria Insomnia primarily attributable to another medical, neurological, psychiatric, or sleep disorder requiring alternative management. Current acute or chronic gastrointestinal inflammatory disease, including inflammatory bowel disease, or acute diarrhea. Known Crohn's disease or ulcerative colitis. Use of systemic corticosteroids, antibiotics, probiotics, or prebiotics within 4 weeks before baseline biomarker sampling. Use of proton pump inhibitors within 2 weeks before baseline stool sampling. Regular use of non-steroidal anti-inflammatory drugs. Enema or colonoscopy within 1 month before stool sampling. Active autoimmune or systemic inflammatory disease, including rheumatoid arthritis. Vaccination within 2 weeks before blood sampling. Acute infection or febrile illness at the time of biomarker assessment. Advanced renal, hepatic, or cardiovascular disease, including estimated glomerular filtration rate \<45 mL/min/1.73 m², advanced hepatic failure, or New York Heart Association class III-IV heart failure. Severe nocturia, defined as ≥3 episodes per night. Known obstructive sleep apnea or a high clinical likelihood of obstructive sleep apnea requiring further diagnostic evaluation. Pregnancy or breastfeeding. Any clinical condition considered by the investigators to interfere substantially with sleep assessment, inflammatory biomarker interpretation, treatment safety, or protocol adherence.

Conditions

Insomnia, Nonorganic Chronic Insomnia Disorder

Locations

Thong Nhat Hospital — Ho Chi Minh City, City, Vietnam

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment