Assessment of degeneration of the auditory nerve by diffusion tensor imaging in unilaterally and bilaterally deaf adults
- Conditions
- deafnesshearing loss1001399510019243
- Registration Number
- NL-OMON45145
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Aged 18 or older
- Normal function of middle ear, i.e., no acute middle ear infections, no tympanic membrane perforations and an air bone gap (which reflects middle-ear function) < 10 dB.;Additional inclusion criteria for unilateral deaf groups (same as in CINGLE trial):
- Hearing in *deaf* ear: hearing threshold for individual frequencies (0.5, 1, 2, 4 kHz) >= 70 dB HL.
- *Deaf* ear has been deaf for no longer than 10 years
- Hearing in *normal* ear: hearing threshold for individual frequencies (0.5, 1, 2, 4 kHz) <= 30 dB HL. Note that near-normal hearing is included by applying a less stringent criterion than for the normal-hearing subjects.;Additional inclusion criteria for bilateral deaf group:
- Admitted by cochlear implant team of the UMCU for cochlear implantation based on various clinical criteria.
-Implanted with a CI from manufacturer MED-EL or Cochlear;Additional inclusion criteria for normal-hearing group:
- Hearing within normal range: hearing threshold for individual frequencies <= 25 dB HL
- Average hearing threshold over 0.5,1,2 and 4 kHz <= 15 dB HL.
A 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. malformation or ossification).
- Disability which could interfere with the completion of the tests (i.e. psychiatric problems).
- Patients with contraindications for Magnetic Resonance Imaging (MRI) - not fulfilling the criteria of the MRI inclusion list, including the presence of a pacemaker and pregnancy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Comparison of fractional anisotropy (FA) and mean diffusivity (MD) of the<br /><br>auditory nerve between normal and deaf sides Furthermore, FA and MD will be<br /><br>correlated with duration of deafness. Other DTI metrics may be considered as<br /><br>well.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Correlation between the DTI parameters and eCAP parameters of patients who<br /><br>receive a CI. Correlation of DTI and eCAP parameters with duration of deafness.<br /><br>Reproducibility of DTI measures.</p><br>