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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taVNS | Device | taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 20 Hz with pulse duration ≤ 1 ms, for 30min,administered twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Visual scale to measure the subjective ear stuffiness symptoms
| Day 0 and postintervention at Week 12 |