NCT00599560

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
Last Updated

March 29, 2016

Status Verified

January 1, 2008

Enrollment Period

7.4 years

First QC Date

January 10, 2008

Last Update Submit

March 28, 2016

Conditions

Keywords

Meniere's diseasestressvasopressinendolymphatic sacV2 receptorcyclic AMPPlasma vasopressin level and V2R mRNA expression level in the endolymphatic sac both were significantly higher in patients with Meniere's disease.In Meniere's disease, there were significant negative co-relationships between vasopressin and V2R.The cyclic AMP activity was basically up-regulated in the endolymphatic sac in Meniere's disease..The cyclic AMP sensitivity for vasopressin was significantly elevated in the endolymphatic sac in Meniere's disease.

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

EXPERIMENTAL

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

2. Acoustic neurinoma

NO INTERVENTION

Diagnosed by CT and/or MRI

Interventions

plasma vasopressin, V2 receptor, cyclic AMP

Also known as: plasma vasopressin, V2 receptor, cyclic AMP
1. Meniere's disease

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Department of Otolaryngology, Osaka University, School of Medicine

Suita, Osaka, 565-0871, Japan

Location

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.

Related Links

MeSH Terms

Conditions

Meniere DiseaseDiabetes InsipidusDiabetes Insipidus, Nephrogenic

Interventions

VasopressinsReceptors, VasopressinCyclic AMP

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsReceptors, NeuropeptideReceptors, NeurotransmitterReceptors, PeptideReceptors, Pituitary HormoneAdenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotides, CyclicNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Tadashi Kitahara, M.D.,Ph.D.

    Department of ORL, Osaka University, School of Medicine

    PRINCIPAL INVESTIGATOR
  • Hiroshi Kiyama, Ph.D.

    Department of Neuroanatomy, Osaka City University, School of Medicine

    STUDY DIRECTOR
  • Takeshi Kubo, M.D.,Ph.D.

    Department of ORL, Osaka University, School of Medicine

    STUDY CHAIR

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

Locations