Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms

NCT07442734 | Recruiting DMC

• 1 other identifier: 2025-KLS-499-01
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia; Insomnia; Brain and Nervous System

Keywords

Auricular Acupressure; Functional Dyspepsia; insomnia; clinical efficacy; Effect mechanism study; Brain functional areas

Outcome Measures

Primary Outcomes (1)

• The effective rate after 2-week treatment

  The overall treatment effect (OTE) after 2 weeks of treatment refers to the proportion of patients who showed significant improvement or improvement.

  2 week

Secondary Outcomes (12)

• 8-week treatment efficacy

  8 week

• Objective sleep quality monitoring

  8 week

• Functional Dyspepsia Symptoms

  baseline, 1 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment

• Emotional State Assessment

  baseline, 2 weeks, 8 weeks after treatment

• Autonomic nervous function assessment

  baseline, 2 weeks, 8 weeks after treatment

Other Outcomes (1)

• Adverse event table

  baseline,2 weeks after treatment, 8 weeks after treatment

Study Arms (2)

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.

Behavioral: Auricular acupressure in concha area

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.

Behavioral: Auricular acupressure in earlobe

Interventions

Auricular acupressure in concha area BEHAVIORAL

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.

Treatment group

Auricular acupressure in earlobe BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Secondary insomnia caused by drugs or other diseases
• Comorbidity with other psychiatric disorders, or severe heart, liver, kidney, or other systemic diseases
• Previously received this treatment method or participated in other clinical trials within the past 6 months
• Presence of contraindications to auricular therapy, such as allergy to skin preparation or damage at the auricular application site
• Pregnant or breastfeeding women
• History of cranial organic lesions, cranial surgery, or severe trauma

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• JianNong Wu

  he First Affiliated Hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JianNong Wu, doctor

CONTACT

13777571598; 13777571598@163.com

mengyuan shen, doctor

CONTACT

18261812250; 1355759459@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During clinical trials, subjects, evaluators, data managers, and statisticians are unaware of treatment assignments. After randomization and allocation by an independent data manager, it is handed over to the nurse, who will not be involved in the results evaluation or data analysis. Neither the study participants nor the investigators had any effect on randomization and assigned hiding. The participants were told there were two treatment options. Two months after the study, patients were asked to complete a blind assessment and a perceived efficacy assessment, and were asked to guess which treatment they had received to test the success of the blind. All researchers will receive training on the methodological specifications of this study prior to the trial and strictly adhere to the principle of task separation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group: Ear seeds with Vaccaria seeds were applied to the earlobe, a region considered to have minimal vagus nerve auricular branch innervation (29). Ear acupressure treatment was performed, with pressure applied until the patient experienced soreness, numbness, heaviness, or distension (30). Frequency: three times daily, within half an hour after meals, for a treatment period of two weeks. The ear seeds were replaced at the hospital once a week.Experimental group: Ear seeds with Vaccaria seeds were applied to the auricular concha, which has a rich distribution of the vagus nerve (31). The method of ear acupressure was the same as above, with pressure applied until the patient experienced soreness, numbness, heaviness, or distension. Frequency: three times daily, within half an hour after meals, for a treatment period of two weeks. The ear seeds were replaced at the hospital once a week.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 2, 2026
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)