An interventional study of Thread embedding acupuncture and Auricular acupressure in Insomnia, Nonorganic and Chronic Insomnia Disorder, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
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.
This is a randomized, participant- and outcome-assessor-blinded, active-controlled, parallel-group clinical trial enrolling 70 adults aged 40 to 75 years with Chronic Insomnia Disorder diagnosed according to the International Classification of Sleep Disorders, Third Edition (ICSD-3).
Eligible participants must also meet prespecified diagnostic criteria for one of two Traditional Chinese Medicine patterns:
Individualized treatment group Participants will receive thread-embedding acupuncture and auricular acupressure using acupoints selected according to their prespecified TCM pattern diagnosis.
Standardized treatment group Participants will receive the same treatment modalities using a fixed set of acupoints applied irrespective of TCM pattern.
Thread-embedding acupuncture will be performed twice, at baseline and Week 4. Auricular acupressure using Vaccaria seeds will be initiated at baseline and renewed every 2 weeks during the 6-week treatment period. Participants will be instructed to self-massage the auricular points for 1-2 minutes per point, 3-5 times daily, particularly approximately 30 minutes before bedtime.
The active treatment period will last 6 weeks, followed by a 4-week post-treatment follow-up, with the final assessment at Week 10. The Week 10 assessment is intended to evaluate the persistence of clinical effects after treatment discontinuation.
Sleep outcomes will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). Adverse events will be monitored throughout the study.
Serum IL-6 and fecal calprotectin will be measured at baseline and Week 6. These biomarkers are considered exploratory mechanistic outcomes representing systemic and gut-related inflammatory activity. Because the study does not directly assess gut microbiota composition, microbial metabolites, intestinal permeability, or central nervous system biomarkers, IL-6 and fecal calprotectin will not be interpreted as direct measures or proof of a microbiota-gut-brain axis mechanism.
Biomarker sampling procedures Baseline biomarker samples will be collected before the first study intervention. If a participant has an acute febrile illness or clinically significant acute infection at a scheduled biomarker assessment, blood and stool sampling may be postponed within a prespecified allowable window according to the biomarker sampling standard operating procedure (SOP). For baseline assessments, the first study intervention will not be initiated until pretreatment biomarker samples have been collected. For the Week 6 assessment, biomarker sampling may be rescheduled within the prespecified allowable window without requiring withdrawal from the clinical study. The participant will remain in the study unless the acute illness otherwise meets a protocol-defined criterion for treatment discontinuation or study withdrawal.
Prespecified analytic components
The study includes two distinct prespecified analytic components:
Randomized treatment-effect analysis The primary analysis will compare the clinical efficacy of individualized TCM pattern-based treatment with the standardized treatment protocol according to randomized treatment assignment. The primary clinical endpoint will be the between-group difference in change in PSQI score from baseline to Week 6.
Changes in ISI, GSRS, IL-6, fecal calprotectin, and adverse events will be evaluated as secondary or exploratory outcomes.
A separate exploratory analysis using pretreatment data only will examine whether Heart-Spleen Deficiency and Liver Qi Stagnation with Spleen Deficiency represent clinically and biologically distinguishable phenotypes. This analysis will examine:
All mechanistic and baseline phenotyping analyses will be considered exploratory and hypothesis-generating.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 70 is close to the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 25, 2026. See what changed
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. (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 .
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 , 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 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 \<45 mL/min/1.73 m², advanced hepatic failure, or 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the same therapeutic modalities-thread-embedding acupuncture and auricular acupressure-using a fixed set of acupoints irrespective of TCM pattern diagnosis. Thread-embedding acupuncture will be administered at baseline and Week 4. Auricular acupressure using Vaccaria seeds will be initiated at baseline and renewed every 2 weeks during the 6-week treatment period. Participants will receive the same self-massage instructions as participants in the individualized treatment group.
Other: Thread embedding acupuncture · Other: Auricular acupressure
Participants will receive thread-embedding acupuncture combined with auricular acupressure. Acupoints will be selected according to the participant's prespecified TCM pattern: * Heart-Spleen Deficiency; or * Liver Qi Stagnation with Spleen Deficiency. Thread-embedding acupuncture will be administered at baseline and Week 4. Auricular acupressure using Vaccaria seeds will be initiated at baseline and renewed every 2 weeks during the 6-week treatment period. Participants will be instructed to self-massage each designated auricular point for 1-2 minutes, 3-5 times daily, particularly approximately 30 minutes before bedtime.
Other: Thread embedding acupuncture · Other: Auricular acupressure
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 with Spleen Deficiency: 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.
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score From Baseline to End of Treatment
The Pittsburgh Sleep Quality Index consists of 19 self-rated items grouped into seven components. Each component is scored from 0 to 3, producing a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. The primary treatment effect will be evaluated as the between-group difference in change in PSQI global score from baseline to the prespecified end-of-treatment assessment.
Time frame: Baseline to Week 6 (End of Treatment)
Change in Insomnia Severity Index (ISI) Score
The Insomnia Severity Index is a 7-item questionnaire assessing the severity and impact of insomnia symptoms. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.
Time frame: Baseline to Week 6 (End of Treatment)
Change in Fecal Calprotectin
Fecal calprotectin will be measured as an exploratory biomarker of gut-related inflammatory activity. Changes will be compared between randomized treatment groups. Fecal calprotectin will not be interpreted as a direct measure of gut microbiota composition or as proof of a microbiota-gut-brain axis mechanism.
Time frame: From baseline to week 6 (End of Treatment)
Change in Serum Interleukin-6 (IL-6)
Serum IL-6 will be measured as an exploratory biomarker of systemic inflammatory activity. Changes will be compared between randomized treatment groups. IL-6 is not considered a diagnostic biomarker of insomnia in this study.
Time frame: From baseline to week 6 (End of Treatment)
Change in PSQI Global Score During Treatment and Follow-up
PSQI global scores will also be assessed at intermediate and post-treatment follow-up visits to characterize the trajectory and persistence of treatment effects.
Time frame: Baseline, Week 4, Week 6, and Week 10 (4-week post-intervention follow-up)
Change in ISI Score During Treatment and Follow-up
ISI scores will be assessed repeatedly to characterize changes in insomnia severity during treatment and after treatment discontinuation.
Time frame: Baseline, Week 4, Week 6, and Week 10 (4-week post-intervention follow-up)
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
The GSRS will be used to assess gastrointestinal symptom burden during the study. Higher scores indicate greater gastrointestinal symptom severity.
Time frame: Baseline, Week 6, and Week 10 (4-week post-intervention follow-up)
Incidence of Treatment-Emergent Adverse Events
Treatment-related and treatment-emergent adverse events, including local pain, bleeding, bruising, dizziness, fainting, infection, skin irritation, or other unexpected events, will be systematically recorded. Event severity, relationship to treatment, management, and outcome will be documented.
Time frame: From first intervention through Week 10
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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