Individualized TCM pattern–based thread-embedding acupuncture plus ear acupressure for chronic insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, participant- and outcome-assessor-blinded trial compares two acupuncture-based treatments for chronic insomnia disorder: individualized pattern-based thread-embedding acupuncture with auricular acupressure versus the same modalities applied to a fixed set of points. Participants are adults aged 40–75 diagnosed with chronic insomnia and one of two prescribed TCM patterns (Heart-Spleen Deficiency or Liver Qi Stagnation with Spleen Deficiency). The intervention lasts 6 weeks with a 4-week follow-up, and outcomes include sleep quality measures, immune-inflammatory markers, and other sleep-related parameters. Blood and stool samples are collected per protocol to explore biological correlates. The study aims to determine if tailoring treatment to TCM patterns offers additional benefit over a standardized approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Thong Nhat Hospital
  Ho Chi Minh City, City, Vietnam Recruiting

Study contacts

• Study coordinator: Huong TL Le, MD, MSc
• Email: lanhuong@ump.edu.vn
• Phone: +84-983506700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Acoustic Resonance Therapy versus Cognitive Behavioral Therapy for Chronic Insomnia.

  This will test whether a SONU headband using Acoustic Resonance Therapy or an interactive CBT-I program helps adults with moderate-to-severe chronic insomnia sleep better after six weeks.

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• Comparing two therapies for insomnia treatment

  This study is testing whether a new sleep therapy called Bedtime Restriction Therapy works just as well as the more common Cognitive Behavioral Therapy for Insomnia to help adults with insomnia sleep better.

  Recruiting at 2 sites University of Geneva, Switzerland · Bern, Canton of Bern and 1 other locations · NCT06767137

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.