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
Among 198 studies in Sleep Initiation and Maintenance Disorders with a site in China — 82 open to participants now, 88 under way, 2 of them phase 3. Sleep Initiation and Maintenance Disorders · China.
Among the 198 studies in Sleep Initiation and Maintenance Disorders with a site in China, this one is the 46th largest by planned enrollment of the 162 interventional ones that give a count, is one of 18 that started in 2025, is one of 123 with no phase, reaches primary completion later than 46 of the 87 other live ones, and was the 172nd registered.
2,726 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 728 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →82 of the 198 studies in Sleep Initiation and Maintenance Disorders with a site in China are open now. Recruiting first, the newest first:
Sichuan Academy of Medical Sciences · Sites in China
Ages 18–80
China Medical University, China · Sites in China
Ages 60+
Renmin Hospital of Wuhan University · Sites in China
Ages 18–79
Jiangsu Taizhou People's Hospital · Sites in China
Ages 65+
Huazhong University of Science and Technology · Sites in China
Ages 40–65 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 388 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 206 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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198 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 6 · Phase 3 9 · Phase 4 13
First in 2006; this study’s year is marked. 18 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 176 is above the median of 68 across 2,353 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 88 across the 162 interventional studies, 200 across the 36 observational. Of the 82 that completed or were terminated, 2 (2%) have results posted.
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19 of 198 have an industry lead sponsor. The 10 most frequent:
The First Affiliated Hospital of Zhejiang Chinese Medical University is the lead sponsor of 40 studies on the registry; 20 are open to participants now.
The First Affiliated Hospital of Zhejiang Chinese Medical University has 5 studies filed under Sleep Initiation and Maintenance Disorders — fewer than ten, so there is no comparison to draw.
29 of the studies in Sleep Initiation and Maintenance Disorders with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07738809Capital University of Physical Education and Sports, ChinaEffects of Exercise Intervention on Sleep Quality and Emotional Problems in College Students With Depressive Symptoms | 2026-11 |
| NCT07730762Xijing HospitalA Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During Pregnancy | 2026-11-30 |
| NCT07340268Zan WangThe Effects of Transcranial Current Stimulation on Insomnia | 2026-11-30 |
| NCT07868224Jiangxi University of Traditional Chinese MedicineValidating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials | 2026-12-01 |
| NCT07384429YangPanEffects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease | 2026-12-01 |
Add all 29 to your calendar (.ics) → With an account.
Among the 198 studies in Sleep Initiation and Maintenance Disorders with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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Started Oct 2025 (actual). Primary completion is estimated for Oct 2026, 11 months after the start.
Of 1,211 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 11 months is below that.
Counting every sponsor, half of 1,289 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
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Sleep Initiation and Maintenance Disorders →
The First Affiliated Hospital of Zhejiang Chinese Medical University