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Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

Primary Purpose

Meniere Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
taVNS
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere Disease focused on measuring Transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

40 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tongren Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcutaneous Auricular Vagus Nerve Stimulation

Arm Description

Outcomes

Primary Outcome Measures

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
Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks
DHI to measure the subjective dizziness symptoms.
Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks
Pure Tone Audiometry to measure the audition.

Secondary Outcome Measures

Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks
SF-36 to measure quality of life
Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks
Visual scale to measure the subjective ear stuffiness symptoms

Full Information

First Posted
December 23, 2020
Last Updated
December 23, 2020
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04686695
Brief Title
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere Disease
Keywords
Transcutaneous auricular vagus nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous Auricular Vagus Nerve Stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
taVNS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks
Description
Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms. Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms
Time Frame
Day 0 and postintervention at Week 12
Title
Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks
Description
DHI to measure the subjective dizziness symptoms.
Time Frame
Day 0 and postintervention at Week 12
Title
Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks
Description
Pure Tone Audiometry to measure the audition.
Time Frame
Day 0 and postintervention at Week 12
Secondary Outcome Measure Information:
Title
Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks
Description
SF-36 to measure quality of life
Time Frame
Day 0 and postintervention at Week 12
Title
Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks
Description
Visual scale to measure the subjective ear stuffiness symptoms
Time Frame
Day 0 and postintervention at Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >=18 and Age <=70. Clinical diagnosis of meniere disease. Exclusion Criteria: History of depression, tumors, thyroid disease, diabetes, cardiac diseases. History of Otorhinolaryngology surgery. Pregnant or lactating women.
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

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Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

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