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

Not Applicable

Recruiting

• Conditions: Functional Dyspepsia; Sleep Disturbances
• Interventions: Device: Transcutaneous Auricular Vagal Nerve Stimulation

• Registration Number: NCT05827575
• Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

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.

Study Timeline

• Study Start: 2022-03-30
• Study First Submitted: 2023-01-16
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham-taVNS	Transcutaneous Auricular Vagal Nerve Stimulation	selected scapha of the two ears for 25hz electrical stimulation
taVNS	Transcutaneous Auricular Vagal Nerve Stimulation	selected cavum conchae of the two ears for 25hz electrical stimulation

Primary Outcome Measures

Name	Time	Method
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
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).
Dyspepsia score	after 4 weeks taVNS treatment	Nepean Dyspepsia Index：the symptom severity score and life quality score
Serum melatonin (MLT) level	after 4 weeks taVNS treatment	test the level of serum melatonin
Heart rate variability（HRV）	after 4 weeks taVNS treatment	Assessment of autonomic function with heart rate variability
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

Trial Locations

Locations (1)

The second affiliated hospital of xi'an jiaotong university; 🇨🇳 Xi'an, Shaanxi, China