[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626984":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":63,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhejiang Chinese Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Apply ear seeds containing Vaccaria seeds to the auricular points in the ear concha area, where there is a rich distribution of the vagus nerve (31). The method of pressing the ear points is the same as above, with the pressing force determined by the patient experiencing sensations of soreness, numbness, heaviness, or distension. Frequency: three times daily, pressing the ear points within half an hour after meals, for a treatment duration of two weeks. Once a week, visit the hospital to replace the ear seeds.",[13],"Behavioral: Auricular acupressure in concha area",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","Apply ear seeds with Vaccaria seeds to the earlobe area, which is considered to have minimal vagus nerve auricular branch innervation (29). For auricular acupressure treatment, the pressure should be applied until the patient experiences sensations of soreness, numbness, heaviness, or fullness (30). Frequency: three times daily, pressing the ear points within half an hour after meals, for a treatment duration of 2 weeks. Visit the hospital once a week to replace the ear seeds.",[19],"Behavioral: Auricular acupressure in earlobe",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Auricular acupressure in concha area","The method of pressing beans on auricular points is based on the meridian theory and viscera theory in the basic theory of traditional Chinese medicine, combined with the knowledge of modern medical anatomy, and from the perspective of syndrome differentiation and treatment, relevant auricular points are selected, and appropriate stimulation such as kneading, pressing, pinching and pressing is given to the seeds of Vaccaria seed attached to the concha auricularis, so that the auricular points can produce acid, numbness, swelling and pain slowly and continuously. For therapeutic purposes.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Auricular acupressure in earlobe","The auricular point pressing bean method is based on the meridian theory and viscera theory in the basic theory of traditional Chinese medicine, combined with the knowledge of modern medical anatomy, and from the perspective of syndrome differentiation and treatment, the relevant auricular points are selected, and the seeds attached to the ear lobe, which is the least innervated part of vagus nerve, are given appropriate stimulation such as kneading, pressing, pinching and pressing, so that the auricular points produce acid, numbness, swelling and pain slowly and continuously. For therapeutic purposes.",[15],[32],{"name":33,"affiliation":34,"role":35},"JianNong Wu","he First Affiliated Hospital of Zhejiang Chinese Medical University","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"JianNong Wu, doctor","CONTACT","13777571598","13777571598@163.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"mengyuan shen, doctor","18261812250","1355759459@qq.com",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"First Affiliated Hospital of Zhejiang Chinese Medical University","RECRUITING","Hangzhou","Zhejiang","310006","China","CN",{"type":56,"coordinates":57},"Point",[58,59],120.16142,30.29365,{"lat":59,"lon":58},[62],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100626984","auricular-stimulation-for-functional-dyspepsia-with-insomnia-efficacy-and-mechanisms-100626984",false,"NCT07442734","Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms","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","Inclusion Criteria:\n\n* Meet the diagnostic criteria for functional dyspepsia and sleep disorders (25,26)\n* Pittsburgh Sleep Quality Index score ≥7\n* Right-handed, aged 18 years or above\n* 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\n* Agree to voluntarily participate in this study and sign the informed consent form\n\nExclusion Criteria:\n\n1. Secondary insomnia caused by drugs or other diseases\n2. Comorbidity with other psychiatric disorders, or severe heart, liver, kidney, or other systemic diseases\n3. Previously received this treatment method or participated in other clinical trials within the past 6 months\n4. Presence of contraindications to auricular therapy, such as allergy to skin preparation or damage at the auricular application site\n5. Pregnant or breastfeeding women\n6. History of cranial organic lesions, cranial surgery, or severe trauma","ALL","18 Years",{"count":75,"type":76},176,"ESTIMATED","INTERVENTIONAL",[79],"NA","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.\n\nSleep 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, adverse effects, and concerns regarding long-term use. The pathophysiology of FD is multifactorial and incompletely understood; increasing evidence highlights dysregulation of the brain-gut axis and autonomic nervous system function (12,13). Auricular vagus nerve-related stimulation may influence brainstem neurotransmission, gastric tone\u002Fmotility, and mood (14), suggesting a potentially safe, non-pharmacological approach for FD with comorbid sleep problems. However, the mechanistic links among autonomic regulation, gut microbiota\u002Fshort-chain fatty acids, and FD remain uncertain.\n\nThis study aims to evaluate the clinical efficacy and safety of auricular acupoint stimulation in FD patients with sleep disorders and to explore underlying mechanisms using brain-function assessments together with autonomic and gastrointestinal-related measures.",[82,83,84],"Functional Dyspepsia","Insomnia","Brain and Nervous System",[86,82,87,88,89,90],"Auricular Acupressure","insomnia","clinical efficacy","Effect mechanism study","Brain functional areas","2026-02-24",{"date":93,"type":94},"2026-03-02","ACTUAL",{"date":96,"type":94},"2025-10-30",{"date":98,"type":76},"2026-10-01",{"name":5,"class":6},1]