跳至主要内容
临床试验/NCT06088589
NCT06088589招募中不适用

Cortical Mechanisms of Speech in Noise Perception in Autism and Fragile X Syndrome

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Stanford-Binet Intelligence Scales, Fifth edition (SB-5)

研究概览

简要总结

The goal of this study is to identify which brain regions are active during speech-in-noise perception, as well as how those regions interact. The investigators are studying brain activation during speech-in-noise in autism and controls as well as individuals with Fragile X Syndrome. The main question[s] it aims to answer are: 1) How does the brain's response to background noise affect a person's ability to understand speech? 2) Can visual cues improve hearing in background noise?

Participants will complete the following:

  • hearing tests
  • cognitive and behavioral measures
  • questionnaires about their symptoms
  • both passive and active hearing tasks while brain activity is recorded with a neuroimaging cap Results will be compared between individuals with autism with and without Fragile X Syndrome as well as individuals without autism.

详细描述

Participants will be 15-35 year-olds with autism, Fragile X Syndrome and autism, and a typical developing group, matched on age and sex (n=20 per group). These ages are wide enough to support sufficient recruitment without the potential confound of age-related hearing loss. The investigators will not exclude participants in either autism group based on cognitive ability if they are able to complete study tasks; the investigators expect to determine effects of cognitive and language abilities on neural activation statistically by modeling continuous effects of IQ on findings.

Recruitment Strategy is through email and social media ads, contacting previous study participants who have consented to contact about future studies, and through local and national organizations and foundations, including the National Fragile X Foundation.

Hearing measures will include 1) behavioral audiometry presented via calibrated earphones 2) Otoacoustic Emissions (OAEs) between 2000-8000 Hz. The investigators will use two tasks to measure speech-in-noise perception. The 3) Digits-In-Noise task (DIN) requires participants to repeat single digits spoken in background noise. The loudness of the spoken digits then varies adaptively based on the participant's performance, and a Speech Reception Threshold (SRT) is calculated. The SRT indicates the ratio of speech to noise level in dB at which the participant correctly reports the digit 50% of the time. The investigators will use a variation of the DIN that includes both interaural "in-phase" (Diotic) and "out-of-phase" (Antiphasic) presentation, which allows for characterization of temporal fine structure perception.

The second speech-in-noise task is the 4) Auditory Attention subtest of the Woodcock Johnson III. This task requires no verbal output; instead participants touch or point to the picture of a word that they hear. Background noise is varied, and the individual's ability to correctly identify the word at different speech-to-noise ratios is recorded. The outcome variables for this test include both a raw score of number correct over a range of speech-to-noise ratios and an age-normed standard score. The investigators are using tests that minimize verbal requirements for two reasons. First, this will allow for inclusion of more participants rather than excluding those with cognitive impairment. Second, by minimizing contributions of working memory required for digit strings and use of context clues (as can occur with sentences in noise), the investigators are able to focus on true differences between groups in speech-in-noise perception.

Finally, the investigators will use an audiovisual DIN task where single digit stimuli are paired with the dynamic oval stimulus used in the neuroimaging paradigm to determine behavioral effects of adding a visual stimulus.

研究设计

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

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • normal audiograms (PTA ≤ 20 dB HL)
  • corrected 20/20 vision (Snellen chart)
  • no history of premature birth (prior to 36 weeks gestation)
  • no medications known to affect EEG signal
  • English as the first language
  • Inclusion for the Autism group requires the following:
  • 1) diagnosis of Autism Spectrum Disorder either based on previous ADOS administration and developmental history, or confirmed via ADOS and developmental history
  • Inclusion for the Autism + FXS group requires the following:
  • Documented PCR/Southern Blot genetic testing confirming full mutation FXS
  • Diagnosis of Autism Spectrum Disorder, per Autism group.
  • Inclusion for the Typically Developing group requires the following:
  • no siblings or parents with an Autism Spectrum Disorder or Fragile X Syndrome
  • no current neurological or psychiatric diagnoses

排除标准

  • Hearing loss or uncorrected vision loss
  • history of premature birth (prior to 36 weeks gestation)

研究组 & 干预措施

Speech Sounds

Experimental

Participants will hear repeated speech sounds while wearing a neuroimaging cap.

干预措施: Mismatch negativity (Behavioral)

结局指标

主要结局

Stanford-Binet Intelligence Scales, Fifth edition (SB-5)

时间窗: Baseline

IQ is a standardized measure of both verbal and nonverbal abilities, which will be measured with the Stanford Binet V. Standard scores range from 40-160, with a mean of 100 and higher scores indicating increased cognitive ability.

correlation between neural activation to background noise (fNIRS) and neural differentiation of speech-in-noise (ERP)

时间窗: Baseline

Percent change in oxygenation in auditory cortex while hearing background noise will be correlated with amplitude of the mismatch negativity to deviant sounds. This correlation reflects how neural activation affects neural differentiation for each individual participant

Repetitive Behavior Questionnaire-2

时间窗: Baseline/before baseline

Self or parent report measure of restrictive and repetitive behaviors

hand dexterity ratio from the Purdue Pegboard task

时间窗: Baseline

The number of pegs placed for the left and right hands in a given amount of time in ratio form, reflects relative dexterity of the right and left hands

Speech reception threshold for single digits in noise- auditory only

时间窗: Baseline

The SRT is the ratio between the loudness of speech and the loudness of background noise in decibels at which a participant can correctly report the digit that is presented at 50% accuracy.

Speech reception threshold for single digits in noise- with visual stimuli

时间窗: Baseline

The SRT is the ratio between the loudness of speech and the loudness of background noise in decibels at which a participant can correctly report the digit that is presented at 50% accuracy. A higher SRT indicates more difficulty hearing speech in background noise

Adult Repetitive Behaviours Questionnaire-2

时间窗: Baseline/before baseline

Self or parent report measure of restrictive and repetitive behaviors

Social Responsiveness Scale, Second Edition

时间窗: Baseline/before baseline

self or parent report of symptoms of autism seen in daily life. T scores have a mean of 50 and a range of 32-114, with higher scores indicating more autism symptoms.

Scaled score for auditory attention subtest

时间窗: Baseline

This task is from the Woodcock Johnson III. In this task, participants point to a picture after hearing a word presented in background noise, and accuracy is compared to same-age norms. Scores range from 1-19, with higher scores indicating better accuracy.

correlation between neural activation to speech (fNIRS) and neural differentiation of speech-in-noise (ERP)

时间窗: Baseline

Percent change in oxygenation in auditory cortex while hearing speech alone will be correlated with amplitude of the mismatch negativity to deviant sounds. This correlation reflects how neural activation affects neural differentiation for each individual participant

Sensory Perception Quotient

时间窗: Baseline/before baseline

The Sensory Perception Quotient is a self-reported measure of sensory concerns and symptoms

Sensory Profile 2

时间窗: Baseline/before baseline

The Sensory Profile is a self report or parent report measure of responses to sensory stimuli. Total symptoms are categorized as "much less than others", "less than others", "same as others", "more than others", and "much more than others" for each participant.

Sensory Experiences Questionnaire (SEQ)

时间窗: Baseline/before baseline

The Sensory Experiences Questionnaire is a self report or parent report measure of responses to sensory stimuli in the everyday environment

Edinburgh Handedness questionnaire

时间窗: Baseline/before baseline

self or parent report measure of which hand (left or right) is used for everyday tasks and how consistently

Autism Spectrum Quotient

时间窗: Baseline/before baseline

self or parent report of an individual's experience of autism symptoms in daily life

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 (1)

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