Functional DyspepsiaNCT07442734
Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms
A study testing Auricular acupressure in concha area and Auricular acupressure in earlobe in people with Functional Dyspepsia and Insomnia, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia, Insomnia, Brain and Nervous System
- What is being tested?
- Auricular acupressure in concha area and Auricular acupressure in earlobe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
JianNong Wu, doctor, 13777571598, 13777571598@163.com
About this study
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
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.
Read the 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
- Conditions
- Functional Dyspepsia, Insomnia, Brain and Nervous System
- Being tested
- Auricular acupressure in concha area, Auricular acupressure in earlobe
- Keywords
- Auricular Acupressure, Functional Dyspepsia, insomnia, clinical efficacy, Effect mechanism study, Brain functional areas
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressure in concha areaBehavioural
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.
Auricular acupressure in earlobeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Auricular acupressure in earlobe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 week
Secondary outcomes (12)
8-week treatment efficacy
After 8 weeks of treatment, the proportion of patients with overall treatment effect (OTE) showing significant improvement or improvement;
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 2 weeks, 8 weeks after treatment
Resting-state functional magnetic resonance imaging
- 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 2 weeks, 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start30 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JianNong Wu, Principal investigator, he First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442734
- Sponsor's protocol ID
- 2025-KLS-499-01
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07442734
- Acronym / sponsor ID
- 2025-KLS-499-01
- Conditions
- Functional Dyspepsia, Insomnia, Brain and Nervous System
- Keywords
- Auricular Acupressure, Functional Dyspepsia, insomnia, clinical efficacy, Effect mechanism study, Brain functional areas
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Auricular acupressure in concha areaApply 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. |
| Control group | Sham comparator | Behavioral: Auricular acupressure in earlobeApply 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupressure in concha areaThe 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. | Behavioural | Treatment group |
| Auricular acupressure in earlobeThe 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. | Behavioural | Control group |
Primary outcome
The effective rate after 2-week treatment
Time frame: 2 week
The overall treatment effect (OTE) after 2 weeks of treatment refers to the proportion of patients who showed significant improvement or improvement.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JianNong Wu principal investigator
he First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupressure in concha area and Auricular acupressure in earlobe in people with Functional Dyspepsia and Insomnia, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JianNong Wu, doctor (13777571598, 13777571598@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effective rate after 2-week treatment (time frame: 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.