Ear acupressure for functional dyspepsia with insomnia
Official title: Study on the Efficacy and Mechanism of Auricular Stimulation for Functional Dyspepsia With Insomnia Based on Brain Function: A Single-center, Randomized Controlled Clinical Trial
Run by The First Affiliated Hospital of Zhejiang Chinese Medical University · NCT07442734 · Data updated 2026-11-12
This trial will test whether pressing specific points on the ear can reduce bothersome upper‑abdominal dyspepsia symptoms and improve sleep in adults with functional dyspepsia and insomnia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 176 (estimated) |
| Sponsor | The First Affiliated Hospital of Zhejiang Chinese Medical University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | October 30, 2025 |
| Main results expected | October 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT07442734 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are right-handed, meet diagnostic criteria for functional dyspepsia and insomnia (PSQI ≥7), have avoided specified antibiotics/probiotics/sleep or FD medications for at least two weeks, and can consent and attend the study visits.
✕Probably not a fit
Patients with insomnia secondary to other medical causes, major psychiatric or severe systemic disease, prior receipt of the same auricular therapy or participation in another trial within six months, or those who cannot stop interfering medications are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults who meet diagnostic criteria for functional dyspepsia and insomnia (PSQI ≥7) will receive auricular acupressure applied to defined points on the concha or earlobe following traditional Chinese medicine point selection. The intervention uses point-pressing techniques (e.g., vaccaria seeds) delivered at the study site and participants are required to be off antibiotics, microbiota-related products, sleep-altering drugs, and FD medications for at least two weeks before enrollment. Clinical outcomes will include changes in dyspepsia symptoms and sleep quality measured with validated scales, while mechanistic assessments will explore gut–brain and neural pathways. The trial is conducted at a single center with standardized application of auricular stimulation and scheduled follow-up visits.
Why it matters
Potential benefit: If successful, this could offer a low-risk, non-drug option to reduce dyspepsia symptoms and improve sleep quality.
How similar studies have gone: Auricular acupressure and related acupuncture techniques have shown promise in small trials for gastrointestinal symptoms and sleep, but high-quality large trials remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet the diagnostic criteria for functional dyspepsia and sleep disorders (25,26) * Pittsburgh Sleep Quality Index score ≥7 * Right-handed, aged 18 years or above * Have not taken the following medications for at least 2 weeks prior to enrollment: antibiotics (oral, intramuscular, or intravenous), microbiota-related products (probiotics, prebiotics, and synbiotics, etc.), or any drugs affecting gastrointestinal flora, any drugs or supplements that improve sleep quality or suppress neural activity in the brain, medications related to functional dyspepsia treatment, or other related therapies * Agree to voluntarily participate in this study and sign the informed consent form Exclusion Criteria: 1. Secondary insomnia caused by drugs or other diseases 2. Comorbidity with other psychiatric disorders, or severe heart, liver, kidney, or other systemic diseases 3. Previously received this treatment method or participated in other clinical trials within the past 6 months 4. Presence of contraindications to auricular therapy, such as allergy to skin preparation or damage at the auricular application site 5. Pregnant or breastfeeding women 6. History of cranial organic lesions, cranial surgery, or severe trauma
Where it's running
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First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: JianNong Wu — he First Affiliated Hospital of Zhejiang Chinese Medical University
- Study coordinator: JianNong Wu, doctor
- Email: 13777571598@163.com
- Phone: 13777571598
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.