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

April 12, 2023 updated by: Second Affiliated Hospital of Xi'an Jiaotong University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspepsia score
Time Frame: after 4 weeks taVNS treatment
Nepean Dyspepsia Index：the symptom severity score and life quality score
after 4 weeks taVNS treatment
Sleep score
Time Frame: after 4 weeks taVNS treatment
Pittsburgh Sleep Quality Index
after 4 weeks taVNS treatment
Hamilton Anxiety and Depression Scale score
Time Frame: after 4 weeks taVNS treatment
Score of Hamilton Anxiety and Depression Scale
after 4 weeks taVNS treatment
Gastric slow waves in electrogastrograph
Time Frame: after 4 weeks taVNS treatment
The percentage of the normal gastric slow waves in fasting, fed states and the post-preprandial EGG power ratio
after 4 weeks taVNS treatment
The threshold volume(TV)and maximal volume（MV）
Time Frame: 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).
after 4 weeks taVNS treatment
Heart rate variability（HRV）
Time Frame: after 4 weeks taVNS treatment
Assessment of autonomic function with heart rate variability
after 4 weeks taVNS treatment
Serum melatonin (MLT) level
Time Frame: after 4 weeks taVNS treatment
test the level of serum melatonin
after 4 weeks taVNS treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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