Meniere Disease Clinical Trial
Official title:
Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study
Verified date | December 2020 |
Source | Beijing Tongren Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | May 31, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 66 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tongren Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tongren Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks | Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms. Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms | Day 0 and postintervention at Week 12 | |
Primary | Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks | DHI to measure the subjective dizziness symptoms. | Day 0 and postintervention at Week 12 | |
Primary | Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks | Pure Tone Audiometry to measure the audition. | Day 0 and postintervention at Week 12 | |
Secondary | Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks | SF-36 to measure quality of life | Day 0 and postintervention at Week 12 | |
Secondary | Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks | Visual scale to measure the subjective ear stuffiness symptoms | Day 0 and postintervention at Week 12 |
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