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van CCT (UK)

van CCT (UK)

The ocular Vestibular Evoked Myogenic Potentials (oVEMPs) in patients with Meniere's disease.

- candidate number5366
- NTR NumberNTR1681
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-feb-2009
- Secondary IDs08-388 METC UMC Utrecht
- Public TitleThe ocular Vestibular Evoked Myogenic Potentials (oVEMPs) in patients with Meniere's disease.
- Scientific TitleThe ocular Vestibular Evoked Myogenic Potentials (oVEMPs) in patients with Meniere's disease.
- hypothesisIn patients with Meniere's disease an altered of absent oVEMP-response is seen.
- Healt Condition(s) or Problem(s) studiedMeniere's disease
- Inclusion criteria1. Uni- or bilateral Meniere's disease according to the criteria of the AAO-HNS 1995;
2. Age older 18 years.
- Exclusion criteria1. An interfering cause of vertigo;
2. History of eye-motility disorders;
3. Audiometrically defined conductive hearing loss of more than 20 dB NHL at 500 Hz.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate1-mrt-2010
- Target number of participants40
- InterventionsoVEMP-test.
For the oVEMP-test 5 electrodes will be placed on the face of the patient and an acoustic stimulus will be delivered to the ears with the patient in supine position with raised eyes. The main study parameter is the amplitude and threshold of the oVEMP-response, which will be compared to our clinical standard.
- Primary outcomeTo gain information about the characteristics of the oVEMP-response in patients with Menière’s disease.
- Secondary outcomeTo evaluate the clinical applicability and especially the perceived burden of the oVEMP-test.
- Timepoints01-03-09: Start of study.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESarts-assistent S.M. Winters
- CONTACT for SCIENTIFIC QUERIESarts-assistent S.M. Winters
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryMenière’s disease still poses a diagnostic and therapeutic problem. Currently Menière’s disease is diagnosed according to clinical criteria by the American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) 1995. These criteria are two or more episodes of vertigo, longer than 20 mins, perceptive hearing loss, tinnitus or aural fullness and exclusion of alternative causes of the complaints. Menière’s disease is accompanied by endolymphatic hydrops which probably inflicts damage to the cochlea and the vestibular organ. Current standard vestibular testing (Electronystagmography (ENG)) solely tests the function of one of the five subcomponents of the vestibular organ, the horizontal semicircular canal. In Menière patients the ENG shows variable responses and in many cases this test is normal. An additional vestibular test, the ocular Vestibular Evoked Myogenic Potential (oVEMP) test, can be used to evaluate the function of two other subcomponents, the two otolith organs. In this study we will compare the oVEMP responses of Menière patients to responses in normal subjects.
- Main changes (audit trail)
- RECORD23-feb-2009 - 14-sep-2009

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