Stress Management Therapy for Meniere's Disease (SMT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Meniere's Disease Stress |
Behavioral: Lifestyle |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Reduction of Plasma Vasopressin Level in Patients With Meniere's Disease |
- all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: medication only
medication = anti-diuretics
|
Behavioral: Lifestyle
water intake, tympanic tubing, regular sleep
Other Name: Stress Management Therapy (SMT)
|
|
Active Comparator: medication + water intake
anti-diuretics + water intake (at least 2.0 litters per day)
|
Behavioral: Lifestyle
water intake, tympanic tubing, regular sleep
Other Name: Stress Management Therapy (SMT)
|
|
Active Comparator: medication + tympanic tubing
anti-diuretics + tympanic tubing (under local anesthesia)
|
Behavioral: Lifestyle
water intake, tympanic tubing, regular sleep
Other Name: Stress Management Therapy (SMT)
|
|
Active Comparator: medication + regular sleep
anti-diuretics + regular sleep (regular sleep program under dark everynight)
|
Behavioral: Lifestyle
water intake, tympanic tubing, regular sleep
Other Name: Stress Management Therapy (SMT)
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Tadashi Kitahara, M.D.,Ph.D. | +81-6-6879-3951 ext 3951 | tkitahara@ent.med.osaka-u.ac.jp |
| Contact: Arata Horii, M.D.,Ph.D. | +81-6-6879-3954 ext 3954 | ahorii@ent.med.osaka-u.ac.jp |
| Japan | |
| Department of Otolaryngology, Osaka University, School of Medicine | Recruiting |
| Suita-city, Osaka, Japan, 565-0871 | |
| Contact: Tadashi Kitahara, M.D.,Ph.D. +81-6-6879-3951 ext 3951 tkitahara@ent.med.osaka-u.ac.jp | |
| Contact: Arata Horii, M.D.,Ph.D. +81-6-6879-3954 ext 3954 ahorii@ent.med.osaka-u.ac.jp | |
| Principal Investigator: Tadashi Kitahara, M.D.,Ph.D. | |
| Sub-Investigator: Takao Imai, M.D.,Ph.D. | |
| Principal Investigator: | Tadashi Kitahara, M.D.,Ph.D. | Department of Otolaryngology, Osaka University, School of Medicine |
More Information
Publications:
| Responsible Party: | Tadashi Kitahara / Associate Professor, Department of Otolaryngology & Head and Neck Surgery, Osaka University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01099046 History of Changes |
| Other Study ID Numbers: | yk19700512 |
| Study First Received: | December 27, 2009 |
| Last Updated: | April 3, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Osaka University:
|
Meniere's disease stress management vasopressin V2 receptor |
water intake tympanic tubing regular sleep under dark |
Additional relevant MeSH terms:
|
Meniere Disease Endolymphatic Hydrops Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases Vasopressins Hemostatics Coagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013