NCT06088589 · Children's Hospital Medical Center, Cincinnati
Speech-in-noise Perception in Autism and Fragile X
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Mismatch negativity
Event related potentials are compared between frequent and infrequent speech sounds (i.e., "ba" vs "da").
Primary outcome measures
Speech reception threshold for single digits in noise- auditory only
Time frame: 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
Time frame: 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
Scaled score for auditory attention subtest
Time frame: 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)
Time frame: 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
correlation between neural activation to background noise (fNIRS) and neural differentiation of speech-in-noise (ERP)
Time frame: 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
Sensory Profile 2
Time frame: 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)
Time frame: Baseline/before baseline
The Sensory Experiences Questionnaire is a self report or parent report measure of responses to sensory stimuli in the everyday environment
Sensory Perception Quotient
Time frame: Baseline/before baseline
The Sensory Perception Quotient is a self-reported measure of sensory concerns and symptoms
Repetitive Behavior Questionnaire-2
Time frame: Baseline/before baseline
Self or parent report measure of restrictive and repetitive behaviors
Adult Repetitive Behaviours Questionnaire-2
Time frame: Baseline/before baseline
Self or parent report measure of restrictive and repetitive behaviors
Stanford-Binet Intelligence Scales, Fifth edition (SB-5)
Time frame: 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.
hand dexterity ratio from the Purdue Pegboard task
Time frame: 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
Edinburgh Handedness questionnaire
Time frame: 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
Time frame: Baseline/before baseline
self or parent report of an individual's experience of autism symptoms in daily life
Social Responsiveness Scale, Second Edition
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Hearing loss or uncorrected vision loss
- history of premature birth (prior to 36 weeks gestation)
Where
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced Mar 19, 2026 · Source of record for eligibility and locations