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Clinical Trials/NL-OMON38438
NL-OMON38438
Completed
Not Applicable

Assessment of the condition of the auditory nerve by diffusion tensor imaging: A pilot study - Diffusion tensor imaging of the auditory nerve

niversitair Medisch Centrum Utrecht0 sites10 target enrollmentTBD
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Conditionshearing impairmentsingle-sided deafness1001399510019243

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
hearing impairment
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
10
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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