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

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827575
• Other study ID #: 2022006
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: Fei Dai
• Phone: 13772151298
• Email: daifei68[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Dyssomnias
• Functional Dyspepsia
• Parasomnias
• Sleep Disturbances

Intervention

Device:
• Transcutaneous Auricular Vagal Nerve Stimulation
stimulation on both ear within different area for 4 weeks;parameter:2s on,3s off,0.5ms,25hz

Locations

Country	Name	City	State
China	The second affiliated hospital of xi'an jiaotong university	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspepsia score	Nepean Dyspepsia Index:the symptom severity score and life quality score	after 4 weeks taVNS treatment
Primary	Sleep score	Pittsburgh Sleep Quality Index	after 4 weeks taVNS treatment
Primary	Hamilton Anxiety and Depression Scale score	Score of Hamilton Anxiety and Depression Scale	after 4 weeks taVNS treatment
Primary	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
Primary	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
Primary	Heart rate variability(HRV)	Assessment of autonomic function with heart rate variability	after 4 weeks taVNS treatment
Primary	Serum melatonin (MLT) level	test the level of serum melatonin	after 4 weeks taVNS treatment