Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stress Management Therapy for Meniere's Disease (SMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01099046
Recruitment Status : Recruiting
First Posted : April 6, 2010
Last Update Posted : April 6, 2010
Sponsor:
Information provided by:
Osaka University

Tracking Information
First Submitted Date  ICMJE December 27, 2009
First Posted Date  ICMJE April 6, 2010
Last Update Posted Date April 6, 2010
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2010)
all cause mortality [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stress Management Therapy for Meniere's Disease
Official Title  ICMJE Reduction of Plasma Vasopressin Level in Patients With Meniere's Disease
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Meniere's Disease
  • Stress
Intervention  ICMJE Behavioral: Lifestyle
water intake, tympanic tubing, regular sleep
Other Name: Stress Management Therapy (SMT)
Study Arms  ICMJE
  • No Intervention: medication only
    medication = anti-diuretics
    Intervention: Behavioral: Lifestyle
  • Active Comparator: medication + water intake
    anti-diuretics + water intake (at least 2.0 litters per day)
    Intervention: Behavioral: Lifestyle
  • Active Comparator: medication + tympanic tubing
    anti-diuretics + tympanic tubing (under local anesthesia)
    Intervention: Behavioral: Lifestyle
  • Active Comparator: medication + regular sleep
    anti-diuretics + regular sleep (regular sleep program under dark everynight)
    Intervention: Behavioral: Lifestyle
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2010)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01099046
Other Study ID Numbers  ICMJE yk19700512
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tadashi Kitahara / Associate Professor, Department of Otolaryngology & Head and Neck Surgery, Osaka University School of Medicine
Study Sponsor  ICMJE Osaka University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tadashi Kitahara, M.D.,Ph.D. Department of Otolaryngology, Osaka University, School of Medicine
PRS Account Osaka University
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP