Functional Dyspepsia, Sleep Disturbances
Conditions
Keywords
Transcutaneous Auricular Vagal Nerve Stimulation, Functional Dyspepsia, Sleep Disturbances
Brief summary
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
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.
Interventions
stimulation on both ear within different area for 4 weeks；parameter：2s on，3s off,0.5ms，25hz
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of Functional bloating/distension with Rome IV; 2. Pittsburgh Sleep Quality Index(PSQI)\>7; 3. Aged 18-65 years old；
Exclusion criteria
1. Have taken drugs that may affect gastrointestinal motility and sleep in the past two week; 2. The history of gastrointestinal surgery; 3. With severe heart, liver and kidney diseases; 5.Pregnant and breastfeeding women; 6.Skin allergies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyspepsia score | after 4 weeks taVNS treatment | Nepean Dyspepsia Index：the symptom severity score and life quality score |
| Sleep score | after 4 weeks taVNS treatment | Pittsburgh Sleep Quality Index |
| Hamilton Anxiety and Depression Scale score | after 4 weeks taVNS treatment | Score of Hamilton Anxiety and Depression Scale |
| Gastric slow waves in electrogastrograph | after 4 weeks taVNS treatment | The percentage of the normal gastric slow waves in fasting, fed states and the post-preprandial EGG power ratio |
| The threshold volume(TV)and maximal volume（MV） | after 4 weeks taVNS treatment | 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). |
| Heart rate variability（HRV） | after 4 weeks taVNS treatment | Assessment of autonomic function with heart rate variability |
| Serum melatonin (MLT) level | after 4 weeks taVNS treatment | test the level of serum melatonin |
Countries
China
Contacts
Primary ContactFei Dai
Backup ContactJingyao Li
Outcome results
None listed