Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis

December 19, 2020 updated by: wudong0120, Beijing Tongren Hospital

Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Reflux Esophagitis: a Pilot Study

Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients reflux esophagitis.

Methods: We accrued 29 patients at Beijing TongRen Hospital Affiliated to Capital Medicine University of. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks and 24 weeks. Endoscopy, reflux diagnostic questionnaire (RDQ), gastrointestinal symptom rating scale (GSRS), and SF-36 were performed to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

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 Locations

  • China
      • Beijing, China
        • Wu Dong

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

41 years to 66 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age >=18 and Age <=70.
  2. Clinical diagnosis of reflux diagnostic.

Exclusion Criteria:

  1. History of cirrhosis, renal impairment, tumors, thyroid disease, diabetes, Crohn's disease, or ulcerative colitis.
  2. History of GI or abdominal surgery.
  3. Pregnant or lactating women.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: taVNS
Transcutaneous Auricular Vagus Nerve Stimulation
Device: Transcutaneous Auricular Vagus Nerve Stimulation
to use taVNS to treat Reflux Esophagitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from Baseline in the reflux diagnostic questionnaire(RDQ) at 12 Weeks
Time Frame: Day 0 and postintervention at Week 12
The RDQ was used to assess the subjective reflux symptoms covering a 1-wk recall period. RDQ is categorized into four symptom clusters depicting heartburn, chest pain, acid reflux, and food reflux. The total RDQ scores (eight items) were calculated. Patients with RDQ ≥ 12 points were considered to have a relapse.
Day 0 and postintervention at Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks
Time Frame: Day 0 and postintervention at Week 12
SF-36 to measure quality of life
Day 0 and postintervention at Week 12
Mean change from Baseline in the Gastrointestinal symptom scale(GSRS) rating scale at 12 Weeks
Time Frame: Day 0 and postintervention at Week 12
GSRS to measure the subjective gastrointestinal symptoms
Day 0 and postintervention at Week 12

Collaborators and Investigators

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

Sponsor

Beijing Tongren Hospital

Investigators

  • Principal Investigator: Haihong Lian, Doc, BeijingTongren Hospital, Capital Medical 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)

July 1, 2018

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

November 1, 2020

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (ACTUAL)

December 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 19, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • taVNS-RE-2020

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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