Transcutaneous Auricular Vagal Nerve Stimulation for Functional Dyspepsia With Sleep Disturbances: a Randomized Controlled Trial

Study Overview
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Brief Summary
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Functional dyspepsia(FD) is most common in functional gastrointestinal disorders whose rick factors include sleep disturbances. The medication treatment for functional dyspepsia with sleep disturbances has disadvantages such as addiction and withdrawal symptoms. Transcutaneous auricular vagal nerve stimulation(taVNS) is a new therapeutic method to improve dyspepsia and sleep. Study on taSNS for FD with sleep disturbances has not yet been explored.

Detailed Description
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Functional dyspepsia (FD) is most common in functional gastrointestinal disorders whose risk factors include sleep disturbances. The medication treatment for FD with sleep disturbances has disadvantages such as addiction and withdrawal symptoms. Transcutaneous auricular vagal nerve stimulation (taVNS) is a new therapeutic method to improve dyspepsia and sleep. The study on taVNS for FD with sleep disturbances has not yet been explored.60 participants who have FD and sleep disturbances are recruited from the department of the Second Affiliated Hospital of Xi'an Jiaotong University. Inclusion criteria follows: meeting the ROME IV diagnostic criteria of FD; Pittsburgh Sleep Quality Index(PSQI)>7; aged 18-65 years old; not taking related drugs in past one month; from March 2022 to June 2023; sign informed consent. All patients were randomly divided into 2 groups and respectively treated with taVNS and sham-taVNS for four weeks. PSQI, Nepean dyspepsia index (NDI), electrogastrogram (ECG), nutrient drinking satiety test, Hamilton Anxiety and Depression Scale, heart rate variability (HRV) and serum melatonin (MLT) were recorded at baseline and after 4-week treatment. The effect and mechanism of taVNS for FD with sleep disturbances were investigated by comparing the indexes before and after treatment of taVNS and sham-taVNS groups. The study was proved by the medical ethics committee of the Second Affiliated Hospital of Xi'an Jiaotong University.

Official Title
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Transcutaneous Auricular Vagal Nerve Stimulation for Functional Dyspepsia With Sleep Disturbances: a Randomized Controlled Trial

Conditions
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Functional Dyspepsia, Sleep Disturbances

Intervention / Treatment
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* Device: Transcutaneous Auricular Vagal Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Functional bloating/distension with Rome IV; Pittsburgh Sleep Quality Index(PSQI)>7; Aged 18-65 years old； Exclusion Criteria: Have taken drugs that may affect gastrointestinal motility and sleep in the past two week; The history of gastrointestinal surgery; With severe heart, liver and kidney diseases; 5.Pregnant and breastfeeding women; 6.Skin allergies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: taVNS<br>selected cavum conchae of the two ears for 25hz electrical stimulation | Device: Transcutaneous Auricular Vagal Nerve Stimulation<br>* stimulation on both ear within different area for 4 weeks；parameter：2s on，3s off,0.5ms，25hz<br>|
| Sham Comparator: sham-taVNS<br>selected scapha of the two ears for 25hz electrical stimulation | Device: Transcutaneous Auricular Vagal Nerve Stimulation<br>* stimulation on both ear within different area for 4 weeks；parameter：2s on，3s off,0.5ms，25hz<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspepsia score | Nepean Dyspepsia Index：the symptom severity score and life quality score | after 4 weeks taVNS treatment | 
| Sleep score | Pittsburgh Sleep Quality Index | after 4 weeks taVNS treatment | 
| Hamilton Anxiety and Depression Scale score | Score of Hamilton Anxiety and Depression Scale | after 4 weeks taVNS treatment | 
| Gastric slow waves in electrogastrograph | The percentage of the normal gastric slow waves in fasting, fed states and the post-preprandial EGG power ratio | after 4 weeks taVNS treatment | 
| The threshold volume(TV)and maximal volume（MV） | Nutrient drinking satiety test: drink [100 g milk powder, 50 g chocolate powder (Cola Coa, Idilia Foods), and 1,120 mL water (0.6 Cal/mL, fat:19%, protein: 18%, carbohydrate: 63%)] at a speed of 60mL/min until reaching the threshold volume(TV)and maximal volume（MV). | after 4 weeks taVNS treatment | 
| Heart rate variability（HRV） | Assessment of autonomic function with heart rate variability | after 4 weeks taVNS treatment | 
| Serum melatonin (MLT) level | test the level of serum melatonin | after 4 weeks taVNS treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous Auricular Vagal Nerve Stimulation, Functional Dyspepsia, Sleep Disturbances