Clinical Trials Logo
  1. Home
  2. Functional Dyspepsia
  3. NCT05827575

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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05827575
Study type Interventional
Source Second Affiliated Hospital of Xi'an Jiaotong University
Contact Fei Dai
Phone 13772151298
Email daifei68@hotmail.com
Status Recruiting
Phase N/A
Start date March 30, 2022
Completion date June 30, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04464369 - Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial Phase 4
Completed NCT01671670 - Acupuncture for Patients With Function Dyspepsia Phase 2/Phase 3
Completed NCT00987805 - Efficacy of Banhasasim-tang on Functional Dyspepsia Phase 4
Completed NCT00761358 - To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia Phase 3
Completed NCT00693407 - Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation N/A
Recruiting NCT01240096 - Mirtazapine Versus Placebo in Functional Dyspepsia Phase 4
Recruiting NCT04540549 - Effects of Exercise on Functional Dyspepsia Based on Rome IV N/A
Recruiting NCT03652571 - Nortriptyline for the Treatment of Functional Dyspepsia Phase 3
Recruiting NCT06068114 - Gastric Pathophysiology in Diabetes
Recruiting NCT03825692 - International Clinical Study of Zhizhu Kuanzhong Capsule Phase 4
Not yet recruiting NCT04548011 - Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia N/A
Terminated NCT02567578 - A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia Phase 2
Completed NCT03007433 - Assessment of GI Function to a Large Test Meal by Non-invasive Imaging N/A
Active, not recruiting NCT00990405 - Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia Phase 4
Completed NCT00404534 - Helicobacter Eradication Relief of Dyspeptic Symptoms Phase 3
Completed NCT03043625 - Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia N/A
Completed NCT03225248 - Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia Phase 3
Recruiting NCT05587127 - Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia N/A
Recruiting NCT01021475 - Does Visceral Manipulation Works in Treating Functional Dyspepsia? Phase 1