Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 8:31 AM
Study NCT ID:
NCT07442734
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse event table', 'timeFrame': 'baseline,2 weeks after treatment, 8 weeks after treatment', 'description': 'Patient safety during treatment was assessed by the Adverse Events Table'}], 'primaryOutcomes': [{'measure': 'The effective rate after 2-week treatment', 'timeFrame': '2 week', 'description': 'The overall treatment effect (OTE) after 2 weeks of treatment refers to the proportion of patients who showed significant improvement or improvement.'}], 'secondaryOutcomes': [{'measure': '8-week treatment efficacy', 'timeFrame': '8 week', 'description': 'After 8 weeks of treatment, the proportion of patients with overall treatment effect (OTE) showing significant improvement or improvement;'}, {'measure': 'Objective sleep quality monitoring', 'timeFrame': '8 week', 'description': '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.'}, {'measure': 'Functional Dyspepsia Symptoms', 'timeFrame': 'baseline, 1 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment', 'description': '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.'}, {'measure': 'Emotional State Assessment', 'timeFrame': 'baseline, 2 weeks, 8 weeks after treatment', 'description': '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.'}, {'measure': 'Autonomic nervous function assessment', 'timeFrame': 'baseline, 2 weeks, 8 weeks after treatment', 'description': 'Measurement Method of Autonomic Nervous Function Changes\n\nIn 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).\n\nIn 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.'}, {'measure': 'Subjective sleep quality monitoring', 'timeFrame': 'baseline, 2 weeks, 8 weeks after treatment', 'description': '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.'}, {'measure': 'Resting-state functional magnetic resonance imaging', 'timeFrame': 'baseline, 2 weeks after treatment', 'description': '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'}, {'measure': 'Clinical Functional Dyspepsia Symptoms', 'timeFrame': 'baseline, 1 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment', 'description': '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.'}, {'measure': 'Quality of Life Scale', 'timeFrame': 'baseline, 1 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment', 'description': '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.'}, {'measure': 'Emotional Assessment', 'timeFrame': 'baseline, 2 weeks, 8 weeks after treatment', 'description': '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.'}, {'measure': 'Autonomic nervous assessment', 'timeFrame': 'baseline, 2 weeks, 8 weeks after treatment', 'description': '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.'}, {'measure': 'Subjective sleep monitoring', 'timeFrame': 'baseline, 2 weeks, 8 weeks after treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Auricular Acupressure', 'Functional Dyspepsia', 'insomnia', 'clinical efficacy', 'Effect mechanism study', 'Brain functional areas'], 'conditions': ['Functional Dyspepsia', 'Insomnia', 'Brain and Nervous System']}, 'descriptionModule': {'briefSummary': '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/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.\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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07442734', 'briefTitle': 'Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhejiang Chinese Medical University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2025-KLS-499-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': '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.', 'interventionNames': ['Behavioral: Auricular acupressure in concha area']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': '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.', 'interventionNames': ['Behavioral: Auricular acupressure in earlobe']}], 'interventions': [{'name': 'Auricular acupressure in concha area', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Treatment group']}, {'name': 'Auricular acupressure in earlobe', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'JianNong Wu, doctor', 'role': 'CONTACT', 'email': '13777571598@163.com', 'phone': '13777571598'}], 'facility': 'First Affiliated Hospital of Zhejiang Chinese Medical University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'JianNong Wu, doctor', 'role': 'CONTACT', 'email': '13777571598@163.com', 'phone': '13777571598'}, {'name': 'mengyuan shen, doctor', 'role': 'CONTACT', 'email': '1355759459@qq.com', 'phone': '18261812250'}], 'overallOfficials': [{'name': 'JianNong Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'he First Affiliated Hospital of Zhejiang Chinese Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}