跳至主要内容
临床试验/NCT06317493
NCT06317493招募中不适用

Using Pupillometry to Assess Hearing Thresholds in Young Children With Hearing Impairment

IRCCS Burlo Garofolo5 个研究点 分布在 2 个国家目标入组 180 人开始时间: 2021年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
180
试验地点
5
主要终点
Sensitivity index of pupillometry test

研究概览

简要总结

The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
4 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Normal or corrected-to-normal vision
  • No history of relevant neurological or psychiatric concomitant disease
  • Age: 4-36 months
  • At least 1 months of more after initial fitting of the CI or hearing aid (only for aided subjects)

排除标准

  • Developmental disorders
  • Unwillingness of the subject to participate further

结局指标

主要结局

Sensitivity index of pupillometry test

时间窗: Within 30 minutes from enrolment

The peak and the average pupil dilation will be defined for each trial and the difference between trials below and above the threshold will be defined within each block. The difference between the trials with and without audible stimuli will be assessed using the multiple corrected t- tests. The sensitivity index of the pupillometric exam compared to the audiometry results will be computed for the whole group using a signal detection analysis.

次要结局

未报告次要终点

研究者

发起方
IRCCS Burlo Garofolo
申办方类型
Other
责任方
Sponsor

研究点 (5)

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