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

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05827575

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Dyspepsia Sleep Disturbances	Device: Transcutaneous Auricular Vagal Nerve Stimulation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: taVNS

selected cavum conchae of the two ears for 25hz electrical stimulation

Device: Transcutaneous Auricular Vagal Nerve Stimulation

stimulation on both ear within different area for 4 weeks；parameter：2s on，3s off,0.5ms，25hz

Sham Comparator: sham-taVNS

selected scapha of the two ears for 25hz electrical stimulation

Device: Transcutaneous Auricular Vagal Nerve Stimulation

stimulation on both ear within different area for 4 weeks；parameter：2s on，3s off,0.5ms，25hz

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.