Stress Management Therapy for Meniere's Disease

Study Overview
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Brief Summary
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Attacks in Meniere's disease, characterized by vertigo and hearing loss, are well known to occur repeatedly under stressed environment. Hitherto, its pathology was revealed to be inner ear hydrops through human temporal bone studies in 1938. For the pathogenesis of inner ear hydrops resulting in Meniere's attacks, plasma vasopressin elevation due to stress and V2 receptor overexpression in the inner ear could be essential as a basis of this disease. In the present study, we'd like to find the effective and feasible way to reduce plasma vasopressin level in patients with Meniere's disease.

Detailed Description
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BACKGROUND: For the pathogenesis of inner ear hydrops resulting in Meniere's attacks, plasma vasopressin elevation due to stress and V2 receptor overexpression in the inner ear could be essential as a basis of this disease. In the present study, we'd like to find the effective and feasible way to reduce plasma vasopressin level in patients with Meniere's disease. METHODS: We estimate to enroll 200 Meniere's patients to four study groups in a randomized controlled trial at Osaka University Hospital during this study period 2010-2015. Patients are diagnosed as Meniere's patients according to the 1995 AAO-HNS criteria. Group-I consists of 50 patients who receive just traditional oral intake medication including anti-diuretics. Group-II consists of 50 patients who receive both medication and water intake (at least 2.0 litters per day). Group-III consists of 50 patients who receive both medication and tympanic tubing (under local anesthesia). Group-IV consists of 50 patients who receive both medication and sleep well (regular sleep program under dark everynight). Additional factors to medication in each group are supposed to have influence on hypothalamus. We follow up all these patients at least 12 months and evaluate stress, psychological and dizziness conditions using a couple of questionnaires. We also examine changes in plasma vasopressin level of patients in each group. ESTIMATED RESULTS: Through this study, we can understand the most effective and feasible way to reduce plasma vasopressin level in patients with Meniere's disease. Much more Meniere's patients may be rescued without invasive surgery.

Official Title
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Reduction of Plasma Vasopressin Level in Patients With Meniere's Disease

Conditions
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Meniere's Disease, Stress

Intervention / Treatment
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* Behavioral: Lifestyle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as Meniere's patients according to the 1995 AAO-HNS criteria are included into this study. Exclusion Criteria: Patients refused our prepared four kinds of treatments are excluded from this study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: medication only<br>medication = anti-diuretics | Behavioral: Lifestyle<br>* water intake, tympanic tubing, regular sleep<br>* Other names: Stress Management Therapy (SMT);|
| Active Comparator: medication + water intake<br>anti-diuretics + water intake (at least 2.0 litters per day) | Behavioral: Lifestyle<br>* water intake, tympanic tubing, regular sleep<br>* Other names: Stress Management Therapy (SMT);|
| Active Comparator: medication + tympanic tubing<br>anti-diuretics + tympanic tubing (under local anesthesia) | Behavioral: Lifestyle<br>* water intake, tympanic tubing, regular sleep<br>* Other names: Stress Management Therapy (SMT);|
| Active Comparator: medication + regular sleep<br>anti-diuretics + regular sleep (regular sleep program under dark everynight) | Behavioral: Lifestyle<br>* water intake, tympanic tubing, regular sleep<br>* Other names: Stress Management Therapy (SMT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meniere's disease, stress management, vasopressin, V2 receptor, water intake, tympanic tubing, regular sleep under dark