Speech-in-noise Perception in Autism and Fragile X

NCT06088589 | Recruiting

• 1 other identifier: 2023-0532
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Fragile X Syndrome

Outcome Measures

Primary Outcomes (15)

• Speech reception threshold for single digits in noise- auditory only

  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.

  Baseline

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

  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

  Baseline

• Scaled score for auditory attention subtest

  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.

  Baseline

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

  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

  Baseline

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

  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

  Baseline

• Sensory Profile 2

  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.

  Baseline/before baseline

• Sensory Experiences Questionnaire (SEQ)

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

  Baseline/before baseline

• Sensory Perception Quotient

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

  Baseline/before baseline

• Repetitive Behavior Questionnaire-2

  Self or parent report measure of restrictive and repetitive behaviors

  Baseline/before baseline

• Adult Repetitive Behaviours Questionnaire-2

  Self or parent report measure of restrictive and repetitive behaviors

  Baseline/before baseline

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

  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.

  Baseline

• hand dexterity ratio from the Purdue Pegboard task

  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

  Baseline

• Edinburgh Handedness questionnaire

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

  Baseline/before baseline

• Autism Spectrum Quotient

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

  Baseline/before baseline

• Social Responsiveness Scale, Second Edition

  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.

  Baseline/before baseline

Study Arms (1)

Speech Sounds

EXPERIMENTAL

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

Behavioral: Mismatch negativity

Interventions

Mismatch negativity BEHAVIORAL

Event related potentials are compared between frequent and infrequent speech sounds (i.e., "ba" vs "da").

Speech Sounds

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• \) diagnosis of Autism Spectrum Disorder either based on previous ADOS administration and developmental history, or confirmed via ADOS and developmental history
• Documented PCR/Southern Blot genetic testing confirming full mutation FXS
• Diagnosis of Autism Spectrum Disorder, per Autism group.
• no siblings or parents with an Autism Spectrum Disorder or Fragile X Syndrome
• no current neurological or psychiatric diagnoses
• IQ over 75

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children'S Hospital

Cincinnati, Ohio, 45229-3026, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Fragile X Syndrome

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System

Study Officials

• Elizabeth Smith, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Smith, PhD

CONTACT

513-517-1383; elizabeth.smith3@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 18, 2023
• Study Start: November 10, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will become available prior to publication submission and will remain available for an unlimited time dependent on data repository requirements.

Locations

US (1)