NCT07442734 Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms
| NCT ID | NCT07442734 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Zhejiang Chinese Medical University |
| Condition | Functional Dyspepsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2025-10-30 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 176 participants in total. It began in 2025-10-30 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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, 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/motility, 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/short-chain fatty acids, and FD remain uncertain. This 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.
Eligibility 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
Contact & Investigator
JianNong Wu
PRINCIPAL INVESTIGATOR
he First Affiliated Hospital of Zhejiang Chinese Medical University
Frequently Asked Questions
Who can join the NCT07442734 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Functional Dyspepsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07442734 currently recruiting?
Yes, NCT07442734 is actively recruiting participants. Contact the research team at 13777571598@163.com for enrollment information.
Where is the NCT07442734 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07442734 clinical trial?
NCT07442734 is sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University. The principal investigator is JianNong Wu at he First Affiliated Hospital of Zhejiang Chinese Medical University. The trial plans to enroll 176 participants.