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Completed

NCT Number: NCT00599560

Vasopressin and V2 Receptor in Meniere's Disease

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.

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Key information

Conditions

Meniere Disease Diabetes Insipidus Diabetes Insipidus, Nephrogenic Ear Diseases Endocrine System Diseases Endolymphatic Hydrops Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Labyrinth Diseases Male Urogenital Diseases Otorhinolaryngologic Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otolaryngology, Osaka University, School of Medicine

Suita, Osaka, 565-0871, Japan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Exclusion criteria

  • Any other neuro-otologic diseases.

Treatment and study plan

vasopressin, V2 receptor and cyclic AMP

Genetic

plasma vasopressin, V2 receptor, cyclic AMP

Other names: plasma vasopressin, V2 receptor, cyclic AMP

Primary outcomes

  1. plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls

    Time frame: prospective

Secondary outcomes

  1. cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls

    Time frame: prospective

Sponsors and collaborators

Lead sponsor

Osaka University

Other

Collaborators

  • Osaka City University

Registry information

Important dates

Study start
1998
Primary completion
2005
Study completion
2005
First posted
Jan 23, 2008
Registry last updated
Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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