Stress Management Therapy for Meniere's Disease
關鍵詞
抽象
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
干預/治療
Behavioral: Lifestyle
相
手臂組
臂 | 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 | 是 |
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]