An interventional study of Auricular acupressure in concha area and Auricular acupressure in earlobe in Functional Dyspepsia, Insomnia and Brain and Nervous System, sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University · Not applicable, Interventional, and Treatment
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.
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
Exclusion Criteria:
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
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
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.
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.
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.
Time frame: 2 week
8-week treatment efficacy
After 8 weeks of treatment, the proportion of patients with overall treatment effect (OTE) showing significant improvement or improvement;
Time frame: 8 week
Objective sleep quality monitoring
After the patient agreed to participate in this study, the research team immediately provided the patient with an actigraphy device (ActiGraph wGT3X-BT) and gave detailed instructions on how to use it. Patients were required to wear the device continuously for 7 days before treatment, 2 weeks after treatment, and 10 weeks after treatment to assess their sleep status. The device was worn on the non-dominant wrist. While wearing the wrist actigraphy device, patients were also asked to maintain a sleep diary, recording bedtimes and wake-up times for 7 days, or the times when the device was removed (e.g., for bathing). The actigraphy data, including sleep efficiency, total sleep time, wake time after sleep onset, and sleep fragmentation index, were processed and scored using Actiware 6.0 software.
Time frame: 8 week
Functional Dyspepsia Symptoms
The full unabbreviated title of the scale is Modified Functional Dyspepsia Symptom Diary (FDSD). The score ranges from a minimum of 0 to a maximum of 4 for each symptom item. Higher scores represent more severe symptoms and a worse clinical condition.
Time frame: baseline, 1 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment
Emotional State Assessment
Self-Rating Anxiety Scale (SDS)。The full title of the scale is Self-Rating Anxiety Scale (SDS). Its total score ranges from a minimum of 20 to a maximum of 80. A higher total score indicates a more severe level of anxiety, meaning a worse psychological outcome.
Time frame: baseline, 2 weeks, 8 weeks after treatment
Autonomic nervous function assessment
Measurement Method of Autonomic Nervous Function Changes In the Title field, the measurement for assessing autonomic nervous function changes in FD patients with sleep disorders induced by auricular acupoint stimulation is specified as the Hyperarousal Scale (HAS), a validated hyperarousal assessment tool. Collected HAS data (reflecting autonomic nervous function changes) were aggregated using descriptive statistics (mean ± SD). In the Description field, additional details about the measurement and data summary metric: HAS is a self-reported scale for hyperarousal assessment, closely linked to autonomic nervous function disorders. Before summary, HAS scores were verified for completeness/validity; invalid scores (\>10% missing items) were excluded, and valid scores were aggregated by mean ± SD for subsequent statistical analysis.
Time frame: baseline, 2 weeks, 8 weeks after treatment
Subjective sleep quality monitoring
The Pittsburgh Sleep Quality Index (PSQI)。This scale is a validated instrument used to assess sleep quality over a one-month period. The total score of the PSQI ranges from a minimum of 0 to a maximum of 21. A higher score indicates poorer sleep quality, while a lower score reflects better sleep quality.
Time frame: baseline, 2 weeks, 8 weeks after treatment
Resting-state functional magnetic resonance imaging
1\. Collection time points: baseline, 2 weeks after treatment. 2. Scan preparation: The subjects lie flat on the MRI examination bed and remain still for 10 minutes. They are instructed to keep their eyes closed quietly, breathe steadily, stay awake, avoid thinking activities, and keep their bodies still. Appropriate stimuli are provided to the patients, after which earplugs are used to reduce noise, and foam head cushions and medical tape are used to fix the head to prevent movement. The patient is then placed into the MRI scanner to begin the fMRI scan. 3. Scanning protocol: (1) Scanner parameters: Equipment and parameters: Using the General Electric 3-Tesla Discovery MR 750 whole-body small-aperture scanner (32-channel parallel receiver coil). The scanning protocol includes: 1) Sagittal 3D T1-weighted images: Repetition time (TR) = 7.4 ms; Echo time (TE) = 3.5 ms; Flip angle (FA) = 12°; Acquisition matrix = 256 × 256; Slice thickness = 1 mm, no gap. Duration: 7 minutes; fMRI paramet
Time frame: baseline, 2 weeks after treatment
Clinical Functional Dyspepsia Symptoms
The Gastrointestinal Symptom Rating Scale (GCSI) is a validated instrument for evaluating gastrointestinal symptom severity. Its total score ranges from a minimum of 0 to a maximum of 144. Higher scores reflect more severe gastrointestinal symptoms and a worse clinical condition.
Time frame: baseline, 1 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment
Quality of Life Scale
The Short Form Nepean Dyspepsia Index (SF-NDI) is a validated tool for evaluating health-related quality of life in patients with dyspepsia. The total score ranges from a minimum of 0 to a maximum of 50. A higher SF-NDI score represents a worse quality of life and more severe symptom-related impairment.
Time frame: baseline, 1 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment
Emotional Assessment
Self-Rating Depression Scale (SAS)。Total score range: the minimum score is 20, and the maximum score is 80. A higher total score on the SAS reflects more severe depressive symptoms and a poorer mental health status.
Time frame: baseline, 2 weeks, 8 weeks after treatment
Autonomic nervous assessment
Electrocardiographic signals were collected before treatment, after 2 weeks, and after 8 weeks of treatment using a CREDIT heart rate variability analyzer. Data such as high-frequency values, low-frequency values, low-frequency/high-frequency ratios, and the standard deviation of normal heartbeats were analyzed to investigate the mechanism of auricular acupoint stimulation on autonomic nervous function in FD patients with sleep disorders.
Time frame: baseline, 2 weeks, 8 weeks after treatment
Subjective sleep monitoring
The Insomnia Severity Index (ISI) is a validated tool used to assess the severity of insomnia symptoms. The total score ranges from a minimum score of 0 to a maximum score of 28. In this scale, higher scores indicate more severe insomnia symptoms and a worse clinical condition, while lower scores reflect milder or absent sleep disturbances.
Time frame: baseline, 2 weeks, 8 weeks after treatment
Adverse event table
Patient safety during treatment was assessed by the Adverse Events Table
Time frame: baseline,2 weeks after treatment, 8 weeks after treatment
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders→
The First Affiliated Hospital of Zhejiang Chinese Medical University