Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06088589

Conditions

Autism Spectrum Disorder

Fragile X Syndrome

Eligibility Criteria

Sex: All

Age: 15 - 35

Healthy Volunteers: Accepted

Interventions

Mismatch negativity

Study Details

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

Study ID

NCT06088589

Start date

Nov 10, 2023

Status verified date

Mar, 2026

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

1. normal audiograms (PTA ≤ 20 dB HL)
2. corrected 20/20 vision (Snellen chart)
3. no history of premature birth (prior to 36 weeks gestation)
4. no medications known to affect EEG signal
5. 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:

1. Documented PCR/Southern Blot genetic testing confirming full mutation FXS
2. Diagnosis of Autism Spectrum Disorder, per Autism group.

Inclusion for the Typically Developing group requires the following:

1. no siblings or parents with an Autism Spectrum Disorder or Fragile X Syndrome
2. no current neurological or psychiatric diagnoses
3. IQ over 75

Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Speech Sounds

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

Interventions

Mismatch negativity

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

Primary outcome measure

  • Speech reception threshold for single digits in noise- auditory only [ Time Frame: Baseline ]
  • Speech reception threshold for single digits in noise- with visual stimuli [ Time Frame: Baseline ]
  • Scaled score for auditory attention subtest [ Time Frame: Baseline ]
  • correlation between neural activation to speech (fNIRS) and neural differentiation of speech-in-noise (ERP) [ Time Frame: Baseline ]
  • correlation between neural activation to background noise (fNIRS) and neural differentiation of speech-in-noise (ERP) [ Time Frame: Baseline ]
  • Sensory Profile 2 [ Time Frame: Baseline/before baseline ]
  • Sensory Experiences Questionnaire (SEQ) [ Time Frame: Baseline/before baseline ]
  • Sensory Perception Quotient [ Time Frame: Baseline/before baseline ]
  • Repetitive Behavior Questionnaire-2 [ Time Frame: Baseline/before baseline ]
  • Adult Repetitive Behaviours Questionnaire-2 [ Time Frame: Baseline/before baseline ]
  • Stanford-Binet Intelligence Scales, Fifth edition (SB-5) [ Time Frame: Baseline ]
  • hand dexterity ratio from the Purdue Pegboard task [ Time Frame: Baseline ]
  • Edinburgh Handedness questionnaire [ Time Frame: Baseline/before baseline ]
  • Autism Spectrum Quotient [ Time Frame: Baseline/before baseline ]
  • Social Responsiveness Scale, Second Edition [ Time Frame: Baseline/before baseline ]

Central Contacts and Locations

Central contacts

Elizabeth Smith, PhD

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

Locations

Cincinnati Children'S Hospital

Recruiting

Cincinnati, Ohio, United States, 45229-3026

Contacts

Elizabeth Smith

elizabeth.smith3@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-03-19.