Back to resultsTranscutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis
Primary Purpose
Reflux Esophagitis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous Auricular Vagus Nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Reflux Esophagitis focused on measuring Reflux esophagitis, Transcutaneous auricular vagus nerve stimulation, Gastroesophageal reflux disease
Eligibility Criteria
Inclusion Criteria:
- Age >=18 and Age <=70.
- Clinical diagnosis of reflux diagnostic.
Exclusion Criteria:
- History of cirrhosis, renal impairment, tumors, thyroid disease, diabetes, Crohn's disease, or ulcerative colitis.
- History of GI or abdominal surgery.
- Pregnant or lactating women.
Sites / Locations
- Wu Dong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
taVNS
Arm Description
Transcutaneous Auricular Vagus Nerve Stimulation
Outcomes
Primary Outcome Measures
Mean change from Baseline in the reflux diagnostic questionnaire(RDQ) at 12 Weeks
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.
Secondary Outcome Measures
Mean change from Baseline in the Gastrointestinal symptom scale(GSRS) rating scale at 12 Weeks
GSRS to measure the subjective gastrointestinal symptoms
Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks
SF-36 to measure quality of life
Full Information
NCT ID
NCT04673643
First Posted
December 10, 2020
Last Updated
December 19, 2020
Sponsor
Beijing Tongren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04673643
Brief Title
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Reflux Esophagitis: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflux Esophagitis
Keywords
Reflux esophagitis, Transcutaneous auricular vagus nerve stimulation, Gastroesophageal reflux disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Transcutaneous Auricular Vagus Nerve Stimulation
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
taVNS
Arm Type
Experimental
Arm Description
Transcutaneous Auricular Vagus Nerve Stimulation
Intervention Type
Device
Intervention Name(s)
Transcutaneous Auricular Vagus Nerve Stimulation
Intervention Description
to use taVNS to treat Reflux Esophagitis
Primary Outcome Measure Information:
Title
Mean change from Baseline in the reflux diagnostic questionnaire(RDQ) at 12 Weeks
Description
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.
Time Frame
Day 0 and postintervention at Week 12
Secondary Outcome Measure Information:
Title
Mean change from Baseline in the Gastrointestinal symptom scale(GSRS) rating scale at 12 Weeks
Description
GSRS to measure the subjective gastrointestinal symptoms
Time Frame
Day 0 and postintervention at Week 12
Title
Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks
Description
SF-36 to measure quality of life
Time Frame
Day 0 and postintervention at Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >=18 and Age <=70.
Clinical diagnosis of reflux diagnostic.
Exclusion Criteria:
History of cirrhosis, renal impairment, tumors, thyroid disease, diabetes, Crohn's disease, or ulcerative colitis.
History of GI or abdominal surgery.
Pregnant or lactating women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haihong Lian, Doc
Organizational Affiliation
BeijingTongren Hospital, Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wu Dong
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis
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