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Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms

RecruitingNAAges 18 Years - anyAllThe First Affiliated Hospital of Zhejiang Chinese…
NCT07442734 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Functional dyspepsia (FD) is a chronic disorder of gut-brain interaction characterized by bothersome upper abdominal symptoms arising from the gastroduodenal region. Diagnosis is made after clinical evaluation has excluded structural disease that could explain symptoms (e.g., upper gastrointestinal endoscopy). According to Rome IV criteria, FD is categorized into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), with symptom overlap commonly observed. FD is prevalent worldwide and is associated with substantial impairment in health-related quality of life and a significant socioeconomic burden. Sleep disturbance, anxiety, and depression are frequent in FD and are associated with symptom severity and recurrence. Current management-such as prokinetic agents, acid-suppressive therapy, and psychotropic medications when indicated-can be limited by variable efficacy, ad

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📋 Eligibility rules (as published)
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
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What it tests

  • Auricular acupressure in concha area
  • Auricular acupressure in earlobe
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Where

1 site
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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