NL-OMON45145
Completed
Not Applicable
Assessment of degeneration of the auditory nerve by diffusion tensor imaging in unilaterally and bilaterally deaf adults - Diffusion tensor imaging of the auditory nerve
niversitair Medisch Centrum Utrecht0 sites50 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- deafness
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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