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临床试验/NCT07279441
NCT07279441招募中不适用

Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2025年1月2日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
460
试验地点
2
主要终点
Error rates for word identification tasks across experiments 1-3

研究概览

简要总结

This study examines how cochlear implant users understand and comprehend speech in realistic communication situations. Through six experiments measuring listening effort via pupillometry and discourse comprehension, we will investigate how linguistic context, cognitive demands, and processing time affect speech understanding in CI users, and in normal-hearing controls) to identify factors underlying communication resilience versus vulnerability and develop improved, ecologically valid assessment and rehabilitation strategies.

详细描述

This research study examines how adults using cochlear implants (CIs) understand and comprehend speech in realistic communication situations. While current clinical tests focus on how well CI users can recognize single words and simple sentences, this study investigates whether success in recognizing speech sounds actually translates to understanding the meaning and content of longer conversations and discourse.

The study will include six interconnected experiments examining: (1) how CI users use linguistic context (both adaptively and maladaptively) to understand degraded speech; (2) how listening effort affects comprehension when faced with communicative challenges like remembering multiple sentences or narratives; (3) whether giving listeners control over the speed of speech presentation improves comprehension; and (4) a clinically-applicable version of these assessments.

Throughout the experiments, researchers will measure listening effort using pupillometry (tracking pupil dilation as an index of cognitive effort) combined with behavioral measures of speech recognition and comprehension. Comprehension will be assessed using a validated framework that distinguishes between understanding main ideas versus minor details in discourse passages.

The study will include cochlear implant users and normal-hearing adults listening to degraded speech simulations via vocoders. Participants will range in age from 18 to 80 years. A comprehensive baseline battery will assess perceptual abilities (speech recognition, spectral resolution, temporal processing) and cognitive abilities (working memory, processing speed, executive function).

OBJECTIVES:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects will be otherwise healthy normal-hearing and cochlear implant (CI) adult listeners (between 18 and 80 years old).

排除标准

  • Individuals below 18 years of age.
  • Individuals with evidence of neurologic, vascular or psychiatric disease or dementia, and taking medications that might interfere with task performance.
  • Individuals with a history of language disorders (besides those associated with hearing loss for the CI users). Individuals who are non-native speakers of American English.

结局指标

主要结局

Error rates for word identification tasks across experiments 1-3

时间窗: End experiments 1-3 (up to 9 hours)

Percent correct increase from anomalous sentences to meaningful sentences (semantic gain).

时间窗: End of experiment 1 (up to 3 hours)

Participants will hear 30 meaningful, eight-word sentences to begin. The words from this list of sentences will then be used to create the unstructured word lists and syntactic strings, such that each word would be heard equally as often across the three stimulus conditions. Therefore, each subject will hear a total of 30 meaningful sentences, 30 anomalous strings, and 30 unstructured lists, presented in a counter-balanced design. Recall accuracy for the three conditions will be compared.

Frequency of semantically-driven misrecognitions in lure conditions

时间窗: End of experiment 2 (up to 3 hours)

Subjects will hear word pairs, with the second (target) word of the pair presented in multi-talker babble. There will be three conditions: Neutral prime (the first word is unrelated to the target word, e.g. Jaw-PASS), Semantic prime (the two words are semantic associates, e.g. Row - BOAT), and Semantic lure (the target word is a semantic associate of a similar word e.g. Row - GOAT, where GOAT is a lure for BOAT), thus putting the semantic context in conflict with successful perception. Frequency of semantically-driven misrecognitions in lure conditions will be assessed.

Percent correct Consonant-Nucleus-Consonant (CNC) words across experiments 1-3

时间窗: End experiments 1-3 (up to 9 hours)

Participants' ability to recognize individual spoken words will be assessed using the Consonant-Nucleus-Consonant (CNC) word test. Outcome is based on the percent of key words correctly repeated. Higher score indicate better speech understanding.

Percent correct AzBio sentences across experiments 1-3

时间窗: End experiments 1-3 (up to 9 hours)

The AzBio sentence test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Outcome is based on the percent of AzBio sentences correctly repeated. Higher score indicate better speech understanding.

Percentage of propositions recalled from narrative passages

时间窗: End of experiment 4 (up to 3 hours)

Subjects will hear 24 150- word passages, with one half of the passages being narrative (tell a story with a setting, theme, plot, etc.) and the other half being expository (e.g. instructions from a health care provider). After each passage the subject will be asked to recall as much of the passage content as possible. Higher score indicate better speech understanding.

Ratio of main idea recall to detail recall

时间窗: End of experiment 4 (up to 3 hours)

Subjects will hear recorded narratives and will be asked to recall them as best as they can. The narratives will include main ideas (defined as propositions whose arguments are directly related to the overall meaning of the passage), mid-level propositions (those that take main propositions as their arguments), and details (propositions that take mid-level or other minor propositions as their arguments. Ratio of main idea recall to detail recall will be assessed.

Percentage of true/false statements identified

时间窗: End of experiment 6 (up to 3 hours)

Subjects will hear sentences with syntactic forms known to be graded in comprehension difficulty: active-conjoined sentences (The author insulted the critic // and the critic hired a lawyer), subject-relative sentences (The author that insulted the critic // hired a lawyer), and object-relative sentences (The author that the critic insulted // hired a lawyer). The subject will hear an equal number of each sentence type, where half are presented with self-pacing, and half are presented without interruption. After each sentence the subject will be presented that they must indicate is true or false about the sentence they just heard.

Percent correct increase from unstructured word lists to anomalous sentences (syntactic gain)

时间窗: End of experiment 1 (up to 3 hours)

Participants will hear 30 meaningful, eight-word sentences to begin. The words from this list of sentences will then be used to create the unstructured word lists and syntactic strings, such that each word would be heard equally as often across the three stimulus conditions. Therefore, each subject will hear a total of 30 meaningful sentences, 30 anomalous strings, and 30 unstructured lists, presented in a counter-balanced design. Recall accuracy for the three conditions will be compared.

Number semantically-driven misrecognitions in lure conditions

时间窗: End of experiment 2 (up to 3 hours)

Subjects will hear word pairs, with the second (target) word of the pair presented in multi-talker babble. There will be three conditions: Neutral prime (the first word is unrelated to the target word, e.g. Jaw-PASS), Semantic prime (the two words are semantic associates, e.g. Row - BOAT), and Semantic lure (the target word is a semantic associate of a similar word e.g. Row - GOAT, where GOAT is a lure for BOAT), thus putting the semantic context in conflict with successful perception. Number semantically-driven misrecognitions in lure conditions will be assessed.

Difference in recall accuracy between single-sentence and two-sentence conditions

时间窗: End of experiment 3 (up to 3 hours)

Subjects will undergo four test conditions (two will require remembering only one sentence and the other two will require remembering two sentences). For each condition there will be two combinations of semantic association between the first and second sentence (half will have high predictability, and the other half will have low predictability). Difference in recall accuracy between single-sentence and two-sentence conditions will be assessed.

Difference in comprehension improvement (percentage of proposition's correctly recalled) with self-paced vs. continuous presentation

时间窗: End of experiment 5 (up to 3 hours)

Subjects will hear 24 150- word passages, with one half of the passages being narrative (tell a story with a setting, theme, plot, etc.) and the other half being expository (e.g. instructions from a health care provider). After each passage the subject will be asked to recall as much of the passage content as possible. Subjects will be presented with equal numbers of "self-paced" passages (stopping at major clauses and sentence boundaries, subject decides when to continue) and passages presented without interruption.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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