Vasopressin and V2 Receptor in Meniere’s Disease

Overview

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.

Full Title of Study: “Vasopressin and V2 Receptor in Meniere’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2005

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).

Interventions

  • Genetic: vasopressin, V2 receptor and cyclic AMP
    • plasma vasopressin, V2 receptor, cyclic AMP

Arms, Groups and Cohorts

  • 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.
  • No Intervention: 2. Acoustic neurinoma
    • Diagnosed by CT and/or MRI

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • cyclic AMP activity in the endolymphatic sac in Meniere’s disease vs controls
    • Time Frame: prospective

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Osaka University
  • Collaborator
    • Osaka City University
  • Provider of Information About this Clinical Study
    • Meniere’s disease association at Osaka University, Tadashi Kitahara, M.D.,Ph.D.
  • Overall Official(s)
    • Tadashi Kitahara, M.D.,Ph.D., Principal Investigator, Department of ORL, Osaka University, School of Medicine
    • Hiroshi Kiyama, Ph.D., Study Director, Department of Neuroanatomy, Osaka City University, School of Medicine
    • Takeshi Kubo, M.D.,Ph.D., Study Chair, Department of ORL, Osaka University, School of Medicine

Citations Reporting on Results

Kumagami H, Beitz E, Wild K, Zenner HP, Ruppersberg JP, Schultz JE. Expression pattern of adenylyl cyclase isoforms in the inner ear of the rat by RT-PCR and immunochemical localization of calcineurin in the organ of Corti. Hear Res. 1999 Jun;132(1-2):69-75. doi: 10.1016/s0378-5955(99)00035-0.

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