Vasopressin and V2 Receptor in Meniere's Disease

March 28, 2016 updated by: Osaka University
Summary: Some of sicknesses are well known to be provoked by inadequate adaptation to physical and/or psychogenic stress in their daily life. Meniere's disease is also a common inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized people under stressed life style. Its oto-pathology was firstly revealed in 1938 to be inner ear endolymphatic hydrops through the temporal bone study. To elucidate the neuroscientific relationship between "stress" and "inner ear", we examined plasma vasopressin (the anti-diuretic "stress" hormone) and its receptor, V2R in the endolymphatic sac (the "inner ear" endo-organ for endolymph absorption) in Meniere's patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: Between 1998 and 2006, we enrolled and assigned 105 intractable Meniere's patients to examine plasma vasopressin during remission of vertigo attacks (controls: 30 patients with chronic otitis media). Using the real-time PCR method, we examined V2R mRNA expression in the endolymphatic sac in 12 patients (controls: 6 patients with acoustic neurinoma). By means of cell culture and cyclic AMP assay, we also examined cyclic AMP activity in the endolymphatic sac in 3 patients (controls: 3 patients with acoustic neurinoma).

Study Type

Interventional

Enrollment (Actual)

135

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
        • Department of Otolaryngology, Osaka University, School of Medicine

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

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients were eligible for enrollment if they had received a clinical diagnosis of Meniere's disease according to the 1995 AAO-HNS criteria (Committee, 1995). These criteria can be briefly described as follows:

    1. Repeated attacks of vertigo: A definitive spell is spontaneous vertigo lasting at least 20 minutes. A mixed type of spontaneous nystagmus is observed during attacks.
    2. Fluctuating cochlear symptoms: The hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range.

Exclusion Criteria:

  • Any other neuro-otologic diseases.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1. Meniere's disease
Patients were eligible for enrollment if they had received a clinical diagnosis of Meniere's disease according to the 1995 AAO-HNS criteria (Committee, 1995). These criteria can be briefly described as follows: 1) Repeated attacks of vertigo: A definitive spell is spontaneous vertigo lasting at least 20 minutes. A mixed type of spontaneous nystagmus is observed during attacks. 2) Fluctuating cochlear symptoms: The hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range.
Genetic: vasopressin, V2 receptor and cyclic AMP
plasma vasopressin, V2 receptor, cyclic AMP
Other Names:
  • plasma vasopressin
  • V2 receptor
  • cyclic AMP
NO_INTERVENTION: 2. Acoustic neurinoma
Diagnosed by CT and/or MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls
Time Frame: prospective
prospective

Secondary Outcome Measures

Outcome Measure
Time Frame
cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls
Time Frame: prospective
prospective

Collaborators and Investigators

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

Sponsor

Osaka University

Collaborators

Osaka City University

Investigators

  • Principal Investigator: Tadashi Kitahara, M.D.,Ph.D., Department of ORL, Osaka University, School of Medicine
  • Study Director: Hiroshi Kiyama, Ph.D., Department of Neuroanatomy, Osaka City University, School of Medicine
  • Study Chair: Takeshi Kubo, M.D.,Ph.D., Department of ORL, 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

Helpful Links

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

April 1, 1998

Primary Completion (ACTUAL)

September 1, 2005

Study Completion (ACTUAL)

September 1, 2005

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (ESTIMATE)

January 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tk19661218
  • Osaka Univ. School of Medicine

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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