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临床试验/NL-OMON45145
NL-OMON45145已完成不适用

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 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • 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.

排除标准

  • 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

研究者

发起方
niversitair Medisch Centrum Utrecht

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