Tailored thread-embedding acupuncture and ear acupressure for long-term insomnia

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 to 75 with long-term insomnia (chronic insomnia disorder). It compares acupuncture-style treatments chosen for each person's Traditional Chinese Medicine pattern with the same treatments on fixed points.

Age

40 to 75 years

Sex

All sexes

Disease stage

Chronic insomnia disorder by ICSD-3 criteria. PSQI score ≥5 and ISI total score ≥10. MMSE score >24. A TCM practitioner must find one of two patterns: Heart-Spleen Deficiency, or Liver Qi Stagnation with Spleen Deficiency. People with high blood pressure or diabetes can join if it is stable, with no relevant medicine change in the previous 3 months.

Earlier treatment

No systemic corticosteroids, antibiotics, probiotics or prebiotics within 4 weeks before baseline sampling. No proton pump inhibitors within 2 weeks before stool sampling. No regular use of non-steroidal anti-inflammatory drugs. No enema or colonoscopy within 1 month before stool sampling. No vaccination within 2 weeks before blood sampling.

Main reasons for not taking part

• Insomnia mainly caused by another medical, nerve, mental health or sleep disorder
• Gut inflammation, such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or acute diarrhoea
• Active autoimmune or inflammatory disease, or an acute infection or fever
• Advanced kidney, liver or heart disease, such as eGFR <45 mL/min/1.73 m² or NYHA class III-IV heart failure
• Severe night-time urination (≥3 times per night), known or likely sleep apnea, pregnancy or breastfeeding

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 40 and 75 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• Standardized Fixed-Point ProtocolExisting treatment, for comparison

  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.

  Treatment: Thread embedding acupuncture and Auricular acupressure

• Individualized TCM Pattern-Based ProtocolTreatment being tested

  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.

  Treatment: Thread embedding acupuncture and Auricular acupressure