Stress Management Therapy for Meniere's Disease (SMT)

April 3, 2010 updated by: Osaka University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Suita-city, Osaka, Japan, 565-0871
        • Recruiting
        • Department of Otolaryngology, Osaka University, School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tadashi Kitahara, M.D.,Ph.D.
        • Sub-Investigator:
          • Takao Imai, M.D.,Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: medication only
medication = anti-diuretics
Behavioral: Lifestyle
water intake, tympanic tubing, regular sleep
Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Stress Management Therapy (SMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osaka University

Investigators

  • Principal Investigator: Tadashi Kitahara, M.D.,Ph.D., Department of Otolaryngology, Osaka University, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

December 27, 2009

First Submitted That Met QC Criteria

April 3, 2010

First Posted (Estimate)

April 6, 2010

Study Record Updates

Last Update Posted (Estimate)

April 6, 2010

Last Update Submitted That Met QC Criteria

April 3, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yk19700512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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