Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

Not Applicable

Completed

• Conditions: Meniere Disease
• Interventions: Device: taVNS

• Registration Number: NCT04686695
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease.

Methods: We accrued 25 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-05-31
• Status Verified: 2020-12
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Last Update Submitted: 2024-06-16
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Age >=18 and Age <=70.
2. Clinical diagnosis of meniere disease.

Exclusion Criteria

1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
2. History of Otorhinolaryngology surgery.
3. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcutaneous Auricular Vagus Nerve Stimulation	taVNS	-

Primary Outcome Measures

Name	Time	Method
Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks	Day 0 and postintervention at Week 12	Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms. Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms
Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks	Day 0 and postintervention at Week 12	Pure Tone Audiometry to measure the audition.
Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks	Day 0 and postintervention at Week 12	DHI to measure the subjective dizziness symptoms.

Secondary Outcome Measures

Name	Time	Method
Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks	Day 0 and postintervention at Week 12	Visual scale to measure the subjective ear stuffiness 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

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, China