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Assessment of degeneration of the auditory nerve by diffusion tensor imaging in unilaterally and bilaterally deaf adults

Assessment of degeneration of the auditory nerve by diffusion tensor imaging in unilaterally and bilaterally deaf adults - Diffusion tensor imaging of the auditory nerve

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45145
Enrollment
50
Registered
2015-12-21
Start date
2016-09-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

deafness hearing loss

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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) = 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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Comparison of fractional anisotropy (FA) and mean diffusivity (MD) of the auditory nerve between normal and deaf sides Furthermore, FA and MD will be correlated with duration of deafness. Other DTI metrics may be considered as well.

Secondary

MeasureTime frame
Correlation between the DTI parameters and eCAP parameters of patients who receive a CI. Correlation of DTI and eCAP parameters with duration of deafness. Reproducibility of DTI measures.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)