Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms

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

Overview

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.

Detailed description

In recent years, acupuncture therapy has become one of the most popular modalities within complementary and alternative medicine. Among acupuncture techniques, auricular point pressing therapy has been widely investigated in clinical and mechanistic studies for functional gastrointestinal disorders accompanied by negative emotions. Auricular point pressing therapy is based on the foundational theories of Traditional Chinese Medicine (TCM), specifically the meridian and visceral theories, combined with modern anatomical knowledge. It employs a syndrome differentiation approach to select relevant points on the ear. By applying appropriate rubbing, pressing, kneading, and compression to vaccaria seeds or other medicinal bean

Interventions

• 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 ca
• Behavioral 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

Primary outcome measures

• The effective rate after 2-week treatment [Time frame: 2 week]

Secondary outcome measures (12)

• 8-week treatment efficacy [Time frame: 8 week]
• Objective sleep quality monitoring [Time frame: 8 week]
• Functional Dyspepsia Symptoms [Time frame: baseline, 1 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment]
• Emotional State Assessment [Time frame: baseline, 2 weeks, 8 weeks after treatment]
• Autonomic nervous function assessment [Time frame: baseline, 2 weeks, 8 weeks after treatment]
• Subjective sleep quality monitoring [Time frame: baseline, 2 weeks, 8 weeks after treatment]
• Resting-state functional magnetic resonance imaging [Time frame: baseline, 2 weeks after treatment]
• Clinical Functional Dyspepsia Symptoms [Time frame: baseline, 1 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment]
• Quality of Life Scale [Time frame: baseline, 1 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment]
• Emotional Assessment [Time frame: baseline, 2 weeks, 8 weeks after treatment]
• Autonomic nervous assessment [Time frame: baseline, 2 weeks, 8 weeks after treatment]
• Subjective sleep monitoring [Time frame: baseline, 2 weeks, 8 weeks after treatment]

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

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou

Identifiers

NCT: NCT07442734 · 2025-KLS-499-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗