Assessment of the condition of the auditory nerve by diffusion tensor imaging: A pilot study
- Conditions
- hearing impairmentsingle-sided deafness1001399510019243
- Registration Number
- NL-OMON38438
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients aged 18 or older.
- Normal function of middle ear (i.e. no acute middle ear infections or tympanic membrane perforations). Air bone gap (reflecting middle-ear function) <10 dB.;Additional inclusion criteria for normal hearing group:
- Hearing within normal range: hearing threshold for individual frequencies <= 20 dB HL; the average over 0.5,1,2 and 4 kHz <= 15 dB HL;Additional inclusion criteria for SSD group:
- Hearing in *deaf* ear: hearing threshold for individual frequencies (0.5, 1, 2, 4 kHz) >= 70 dB HL.
- Hearing in *normal* ear: hearing threshold for individual frequencies (0.5, 1, 2, 4 kHz) <= 30 dB HL. Note that near-normal hearing (not normal but no hearing aid needed) is included by applying a less stringent criterion than for the normal-hearing subjects.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Abnormal cochlear anatomy in one or both ears (i.e. ossification).
- Disability which could interfere with the completion of the tests (i.e. psychiatric problems or severe co-morbidity with an expected survival of less than five years).
- Patients with contraindications for Magnetic Resonance Imaging (MRI)
- Not fulfilling the criteria of the MRI inclusion list (see file F), including the presence of any type of metal in the body, tattoos on the skin and pregnancy.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint of this study is the difference between the normal auditory<br /><br>nerve and degenerated auditory nerve. The difference can be quantified with the<br /><br>diffusion parameters fractional anisotropy (FA), apparent diffusion coefficient<br /><br>(ADC), axial diffusivity (AD) and radial diffusivity (RD).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secundary endpoint of the study is the comparison between the normal nerve<br /><br>in SSD patients and the normal nerve in healthy controls. </p><br>