CompletedNot Applicable

Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

China25 participantsStarted 2018-03-01

Plain-language 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.

Who can participate

Age range

40 Years – 66 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks

Timeframe: Day 0 and postintervention at Week 12

Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks

Timeframe: Day 0 and postintervention at Week 12

Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks

Timeframe: Day 0 and postintervention at Week 12

Trial details

NCT IDNCT04686695

SponsorBeijing Tongren Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Meniere Disease trials

Plain-language summary

Who can participate

Age range

40 Years – 66 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks

Timeframe: Day 0 and postintervention at Week 12

Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks

Timeframe: Day 0 and postintervention at Week 12

Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks

Timeframe: Day 0 and postintervention at Week 12