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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04686695
Other study ID # taVNS-MD-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date May 31, 2020

Study information

Verified date December 2020
Source Beijing Tongren Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
taVNS
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.

Locations

Country Name City State
China Beijing Tongren Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

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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