Cochlear-Implant-Performance-Prediction
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- SNR-loss (dB)
研究概览
简要总结
Despite improved technology, many cochlear implant (CI) recipients still struggle to understand speech in noise (SIN). Because the bottom-up acoustic signal generated by the implant is distorted relative to normal-hearing acoustic input, CI users rely more on top-down processing to decipher masked speech. To better predict outcomes for CI recipients, top-down auditory processing ability should be assessed. However, hearing impairment makes testing top-down auditory processing ability through auditory means difficult. The study aims to determine whether testing visual top-down processing can predict auditory top-down processing capability.
详细描述
Participants will complete a proctored, 25-minute computer-based test battery of visual cognitive tests (Stroop Test, Trail-Making Tests), visual distorted-signal tests (Scrambled Letters, VisualSNR), and auditory threshold tests (QuickSIN, Hearing Test). To prevent the accumulation of mental fatigue, tests will be administered in a predetermined order designed to minimize it. Including time for explanations for each test and questions from the participant about the testing protocol, the total time the participant will spend on the study is approximately 45 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants who do not fit the
排除标准
- •Exclusion Criteria:
- •Individuals who are not yet adults (infants, children, teenage children),
- •Adults unable to consent,
- •Adults with known impaired decision-making capacity,
- •Pregnant women,
- •Prisoners (or other detained/paroled individuals),
- •Students or postdoctoral trainees who are taught by or academically mentored by the Principal Investigator, in compliance with the Enrollment of Students and Trainees in Research Studies policies.
- •Non-fluent English speakers, Tests (specifically Scrambled Letters and QuickSIN) require proficiency in the English language.
- •Individuals with severe hearing impairment, Tests (specifically QuickSIN) require participants to not have trouble hearing speech.
- •Individuals with significant, uncorrected visual impairment. All visual tests require the participant to be able to read medium-sized text on a screen approximately two feet in front of them.
研究组 & 干预措施
performance assessment
干预措施: cochlear implant user performance prediction (Diagnostic Test)
结局指标
主要结局
SNR-loss (dB)
时间窗: 3 minutes
The Quick Sound-in-Noise (QuickSIN) test is a common method for assessing speech-in-noise perception. In this test, participants listen to sentences spoken by a female speaker in increasingly loud four-talker babble. The signal-to-noise ratio (SNR) loss for two QuickSIN tests will be averaged and recorded.
Audiogram
时间窗: 7 minutes
Behavioral hearing threshold
Stroop times
时间窗: 2 minutes
The Stroop Test assesses inhibition-concentration. This test consists of two sets of subtests. Each subtest requires reading 25 words from a table of colored words: the first subtest requires the participant to read the word, and the second requires the participant to name the color of the word. In the first set of subtests, the words will be colored corresponding to the meaning of the color word (i.e. 'Red' will be colored red). In the second set of subtests, the words will be colored in a different color than the meaning of the word (i.e.' Red' will be colored purple). The completion time of each subtest will be recorded.
Trail times
时间窗: <3 minutes
The Trail-Making Test (TMT) assesses attention and processing speed. This test consists of subtests A and B. In part A, the participant must connect dots numbered 1-25 in numerical order. In part B, the participant must connect dots numbered 1-13 and dots labeled A-L in alternating order (i.e. 1-A-2-B). If the participant makes a mistake, they must correct the mistake before moving on. The completion time of each subtest will be recorded.
Percent identified
时间窗: 11 minutes
The Scrambled Letters and VisualSNR tests were developed to assess the participant's ability to decipher garbled or distorted visual stimuli.
SNR-loss (dB)
时间窗: baseline
The Quick Sound-in-Noise (QuickSIN) test is a common method for assessing speech-in-noise perception. In this test, participants listen to sentences spoken by a female speaker in increasingly loud four-talker babble. The signal-to-noise ratio (SNR) loss for two QuickSIN tests will be averaged and recorded.
Audiogram
时间窗: baseline
Behavioral hearing threshold
Stroop times
时间窗: baseline
The Stroop Test assesses inhibition-concentration. This test consists of two sets of subtests. Each subtest requires reading 25 words from a table of colored words: the first subtest requires the participant to read the word, and the second requires the participant to name the color of the word. In the first set of subtests, the words will be colored corresponding to the meaning of the color word (i.e. 'Red' will be colored red). In the second set of subtests, the words will be colored in a different color than the meaning of the word (i.e.' Red' will be colored purple). The completion time of each subtest will be recorded.
Trail times
时间窗: baseline
The Trail-Making Test (TMT) assesses attention and processing speed. This test consists of subtests A and B. In part A, the participant must connect dots numbered 1-25 in numerical order. In part B, the participant must connect dots numbered 1-13 and dots labeled A-L in alternating order (i.e. 1-A-2-B). If the participant makes a mistake, they must correct the mistake before moving on. The completion time of each subtest will be recorded.
Percent identified
时间窗: baseline
The Scrambled Letters and VisualSNR tests were developed to assess the participant's ability to decipher garbled or distorted visual stimuli.
次要结局
未报告次要终点
研究者
Claus-Peter Richter, MD, PhD
Professor
Northwestern University