Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Meniere Disease
- Sponsor
- Beijing Tongren Hospital
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>=18 and Age \<=
- •Clinical diagnosis of meniere disease.
Exclusion Criteria
- •History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
- •History of Otorhinolaryngology surgery.
- •Pregnant or lactating women.
Outcomes
Primary Outcomes
Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks
Time Frame: 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
Time Frame: 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
Time Frame: Day 0 and postintervention at Week 12
DHI to measure the subjective dizziness symptoms.
Secondary Outcomes
- Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks(Day 0 and postintervention at Week 12)
- Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks(Day 0 and postintervention at Week 12)