Stress Management Therapy for Meniere's Disease (SMT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2010 by Osaka University
Sponsor:
Information provided by:
Osaka University
ClinicalTrials.gov Identifier:
NCT01099046
First received: December 27, 2009
Last updated: April 3, 2010
Last verified: April 2010
  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

Resource links provided by NLM:


Further study details as provided by Osaka University:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099046

Contacts
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

Locations
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.         
Sponsors and Collaborators
Osaka University
Investigators
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 July 22, 2014