NCT06088589 Speech-in-noise Perception in Autism and Fragile X
| NCT ID | NCT06088589 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-11-10 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-11-10 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Elizabeth Smith, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT06088589 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 35 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06088589 currently recruiting?
Yes, NCT06088589 is actively recruiting participants. Contact the research team at elizabeth.smith3@cchmc.org for enrollment information.
Where is the NCT06088589 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06088589 clinical trial?
NCT06088589 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Elizabeth Smith, PhD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 60 participants.