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临床试验/NCT03212924
NCT03212924已完成不适用

Evaluation of Listening Effort With Pupillometry in Cochlear Implant Users

Oticon Medical2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Latency of peak of pupil dilatation (ms)

研究概览

简要总结

Listening with a cochlear implant remains difficult and most listeners will report high levels of listening effort.The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users. The listening effort is measured with pupillometry, by monitoring the variations of pupil size in response to different stimuli. The size of the pupil is known to increase with the listening effort. The listening effort is evaluated in two different situation: speech perception in quiet and speech perception in noise. The pupillometry measures will be compared for the two listening conditions. Moreover, the study will evaluate the relationship between objective (pupil dilatation) and subjective measures (auto evaluation) of listening effort, and between speech comprehension, cognitive abilities and listening effort.

详细描述

Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound sensorineural hearing loss. Most CI users can understand speech in quiet, but comprehension scores drop in the presence of background noise and in adverse conditions. Listening with a cochlear implant remains very demanding and most listeners report high levels of listening effort. The aim of current auditory prostheses and cochlear implants is not only restore speech understanding, but also to restore all the cognitive functions that are associated to a listening task (e.g., memory, executive functions, attention). Evaluating the listening effort is a new way to assess the efficiency of the hearing aids or cochlear implants. The listening effort indicates the amount of cognitive resources that are dedicated to a listening task; it evaluates also the cognitive resources remaining available for the other cognitive functions. The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users. The listening effort is measured with pupillometry, i. e. by measuring the pupil dilatation in response to different stimuli. The size of the pupil is known to increase with the listening effort. The listening effort is evaluated in two different situation: speech perception in quiet and speech perception in noise. Speech comprehension is measured for the two listening conditions and cognitive functions are assessed by the MOCA (Montreal Cognitive Assessment). In addition, the subjects are asked to subjectively evaluate the amount of listening effort they used in each listening situation. The pupillometry measures will be compared for the two listening conditions. Moreover, the study will evaluate the relationship between objective (pupil dilatation) and subjective measures (self evaluation) of listening effort, and between speech comprehension, cognitive abilities and listening effort.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • informed consent
  • Native French speaker or fluent French speaker
  • Patient already fitted with one or two cochlear implants Oticon Medical
  • Can correctly identify at least 10 % of the words in monosyllabic Lafon lists in quiet
  • Normal or corrected to normal vision

排除标准

  • vulnerable patients (kids, pregnant women, persons under guardianship)
  • No Social security affiliation
  • blindness

研究组 & 干预措施

Pupillometry

Experimental

Measure of pupil dilatation while listening to speech (monosyllabic words) in quiet and in noise.

Evaluation of speech comprehension in quiet

Evaluation of speech comprehension in noise

Measure of cognitive functions with the MOCA (Montreal Cognitive Assessment)

Auto evaluation of listening effort in quiet

Auto evaluation of listening effort in noise

干预措施: MOCA (Behavioral)

Pupillometry

Experimental

Measure of pupil dilatation while listening to speech (monosyllabic words) in quiet and in noise.

Evaluation of speech comprehension in quiet

Evaluation of speech comprehension in noise

Measure of cognitive functions with the MOCA (Montreal Cognitive Assessment)

Auto evaluation of listening effort in quiet

Auto evaluation of listening effort in noise

干预措施: Pupillometry (Behavioral)

Pupillometry

Experimental

Measure of pupil dilatation while listening to speech (monosyllabic words) in quiet and in noise.

Evaluation of speech comprehension in quiet

Evaluation of speech comprehension in noise

Measure of cognitive functions with the MOCA (Montreal Cognitive Assessment)

Auto evaluation of listening effort in quiet

Auto evaluation of listening effort in noise

干预措施: Evaluation of speech comprehension in quiet (Behavioral)

Pupillometry

Experimental

Measure of pupil dilatation while listening to speech (monosyllabic words) in quiet and in noise.

Evaluation of speech comprehension in quiet

Evaluation of speech comprehension in noise

Measure of cognitive functions with the MOCA (Montreal Cognitive Assessment)

Auto evaluation of listening effort in quiet

Auto evaluation of listening effort in noise

干预措施: Evaluation of speech comprehension in noise (Behavioral)

Pupillometry

Experimental

Measure of pupil dilatation while listening to speech (monosyllabic words) in quiet and in noise.

Evaluation of speech comprehension in quiet

Evaluation of speech comprehension in noise

Measure of cognitive functions with the MOCA (Montreal Cognitive Assessment)

Auto evaluation of listening effort in quiet

Auto evaluation of listening effort in noise

干预措施: auto evaluation of listening effort in quiet (Behavioral)

Pupillometry

Experimental

Measure of pupil dilatation while listening to speech (monosyllabic words) in quiet and in noise.

Evaluation of speech comprehension in quiet

Evaluation of speech comprehension in noise

Measure of cognitive functions with the MOCA (Montreal Cognitive Assessment)

Auto evaluation of listening effort in quiet

Auto evaluation of listening effort in noise

干预措施: auto evaluation of listening effort in noise (Behavioral)

结局指标

主要结局

Latency of peak of pupil dilatation (ms)

时间窗: 1 hour

The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. The peak is defined as the point in time where the maximum of pupil dilatation occurs. The latency of the peak of dilatation is compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).

Amplitude of peak of pupil dilatation

时间窗: 1 hour

The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. The peak is defined as the point in time where the maximum of pupil dilatation occurs. The amplitude of the peak of dilatation is compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).

Pupil dilatation (mm)

时间窗: 1 hour

The listening effort while listening to speech stimuli is estimated by measuring the pupil size relative to a baseline. Measures of pupil dilatation are compared between quiet and noisy conditions (+ 10 SNR: signal to noise ratio).

次要结局

  • VAS quiet(1 min)
  • VAS noise(1 min)
  • Speech intelligibility in quiet(30 mins simultaneously to pupillometry measures)
  • Speech intelligibility in noise(30 mins simultaneously to pupillometry measures)
  • MOCA (Montreal Cognitive assessment)(15 mins)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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Listening Effort in Cochlear Implant Users | 临床试验