RecruitingNot Applicable

Speech-in-noise Perception in Autism and Fragile X

United States60 participantsStarted 2023-11-10

Plain-language 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.

Who can participate

Age range

15 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Speech reception threshold for single digits in noise- auditory only

Timeframe: Baseline

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

Timeframe: Baseline

Scaled score for auditory attention subtest

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Sensory Profile 2

Timeframe: Baseline/before baseline

Sensory Experiences Questionnaire (SEQ)

Timeframe: Baseline/before baseline

Trial details

NCT IDNCT06088589

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

Elizabeth Smith, PhD

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

View on ClinicalTrials.gov More Autism Spectrum Disorder trials

Plain-language summary

Who can participate

Age range

15 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
. 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

What they're measuring

Speech reception threshold for single digits in noise- auditory only

Timeframe: Baseline

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

Timeframe: Baseline

Scaled score for auditory attention subtest

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Sensory Profile 2

Timeframe: Baseline/before baseline

Sensory Experiences Questionnaire (SEQ)

Timeframe: Baseline/before baseline