Vasopressin and V2 Receptor in Meniere's Disease
2 other identifiers
interventional
135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 1998
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 10, 2008
CompletedFirst Posted
Study publicly available on registry
January 23, 2008
CompletedMarch 29, 2016
January 1, 2008
7.4 years
January 10, 2008
March 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls
prospective
Secondary Outcomes (1)
cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls
prospective
Study Arms (2)
1. Meniere's disease
EXPERIMENTALPatients 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.
2. Acoustic neurinoma
NO INTERVENTIONDiagnosed by CT and/or MRI
Interventions
plasma vasopressin, V2 receptor, cyclic AMP
Eligibility Criteria
You may qualify if:
- 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:
- 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.
- Fluctuating cochlear symptoms: The hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range.
You may not qualify if:
- Any other neuro-otologic diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Osaka Universitylead
- Osaka City Universitycollaborator
Study Sites (1)
Department of Otolaryngology, Osaka University, School of Medicine
Suita, Osaka, 565-0871, Japan
Related Publications (1)
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.
PMID: 10392549RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 10, 2008
First Posted
January 23, 2008
Study Start
April 1, 1998
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
March 29, 2016
Record last verified: 2008-01