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Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease

NCT05328895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-10-31

No results posted yet for this study

Summary

Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease. Methods: We enrolled 88 patients at Beijing TongRen Hospital. 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. Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.

Conditions

  • Meniere Disease

Interventions

OTHER

Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on the left ear was selected and stimulated with electronic acupuncture apparatus (Hwato, SDZ-IIB), with continuous wave, 25 Hz in frequency, 4 to 8 mA in intensity depending on patient's tolerance. The first 3 treatments were conducted in hospital, during which, the patients were trained to use the apparatus under the instruction of research staff. Afterwards, the rest treatments were exerted at home, twice a day, after every breakfast and dinner respectively, 30 min each time. The treatment was given from Monday to Friday a week, totally for 12 weeks. Participants received betahistine mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-01-01
Completion
2022-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05328895 on ClinicalTrials.gov