Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis

Sponsor

Beijing Tongren Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04673643

Collaborator

(none)

Enrollment

Location

Arm

28.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Reflux Esophagitis	Device: Transcutaneous Auricular Vagus Nerve Stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Transcutaneous Auricular Vagus Nerve StimulationTranscutaneous Auricular Vagus Nerve Stimulation

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2018

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Nov 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: taVNS

Transcutaneous Auricular Vagus Nerve Stimulation

Device: Transcutaneous Auricular Vagus Nerve Stimulation

to use taVNS to treat Reflux Esophagitis

Outcome Measures

Primary Outcome Measures

Mean change from Baseline in the reflux diagnostic questionnaire(RDQ) at 12 Weeks [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

41 Years to 66 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.