Vasopressin and V2 Receptor in Meniere's Disease

Not Applicable

Completed

• Conditions: Meniere Disease
• Interventions: Genetic: vasopressin, V2 receptor and cyclic AMP

• Registration Number: NCT00599560
• Lead Sponsor: Osaka University

Brief Summary

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.

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 Timeline

• Study Start: 1998-04
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2008-01
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-23
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Meniere's disease	vasopressin, V2 receptor and cyclic AMP	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.

Primary Outcome Measures

Name	Time	Method
plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls	prospective

Secondary Outcome Measures

Name	Time	Method
cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls	prospective

Trial Locations

Locations (1)

Department of Otolaryngology, Osaka University, School of Medicine; 🇯🇵 Suita-city, Osaka, Japan