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Completed

NCT Number: NCT04686695

Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

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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Key information

Conditions

Meniere Disease Ear Diseases Endolymphatic Hydrops Labyrinth Diseases Otorhinolaryngologic Diseases

Age range

40 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks

    Time frame: Day 0 and postintervention at Week 12

    SF-36 to measure quality of life

  2. Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks

    Time frame: Day 0 and postintervention at Week 12

    Visual scale to measure the subjective ear stuffiness symptoms

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 29, 2020
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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