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Stress Management Therapy for Meniere's Disease

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狀態
贊助商
Osaka University

關鍵詞

抽象

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.

描述

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.

日期

最後驗證: 03/31/2010
首次提交: 12/26/2009
提交的預估入學人數: 04/02/2010
首次發布: 04/05/2010
上次提交的更新: 04/02/2010
最近更新發布: 04/05/2010
實際學習開始日期: 12/31/2008
預計主要完成日期: 12/31/2014
預計完成日期: 12/31/2019

狀況或疾病

Meniere's Disease
Stress

干預/治療

Behavioral: Lifestyle

-

手臂組

干預/治療
No Intervention: medication only
medication = anti-diuretics
Active Comparator: medication + water intake
anti-diuretics + water intake (at least 2.0 litters per day)
Active Comparator: medication + tympanic tubing
anti-diuretics + tympanic tubing (under local anesthesia)
Active Comparator: medication + regular sleep
anti-diuretics + regular sleep (regular sleep program under dark everynight)

資格標準

有資格學習的性別All
接受健康志願者
標準

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.

結果

主要結果指標

1. all cause mortality [one year]

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