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Understanding Sound Perception in Young Children with Fragile X Syndrome

This study aims to understand how young children with Fragile X Syndrome (FXS) process sounds and learn language. We know that children with FXS often have delays in speech and language, and can be very sensitive to sounds. This research will use special tests, including brain imaging (fNIRS/EEG) while children listen to different speech sounds, to see how their brains respond. We're looking for children aged 2 to 4 years old with FXS, typically developing children, or children born prematurely. The goal is to better understand the brain activity related to sound perception and language development in FXS, which could help predict language difficulties and guide future treatments. This study is currently recruiting 90 participants.

Study design
This interventional study plans to enroll 90 participants, including children with Fragile X Syndrome, typically developing children, and children with a history of premature birth. It will use fNIRS/EEG to measure brain responses to sounds.
What's involved
You would participate in a single study visit between the ages of 2 and 4 years. During this visit, your child will undergo behavioral assessments of speech and language abilities, neuroimaging, and hearing tests.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken at a single study visit between the ages of 2-4 years; there is no specified follow-up period after this visit.

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NCT05957549

Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG-Preschool Age

Recruiting
NAAges 24–4InterventionalBasic science
Children's Hospital Medical Center, Cincinnati
~90 participants
Updated 2025-07-10 on ClinicalTrials.gov
What's tested:Speech discrimination

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Mullen Scales of Early Learning
Measured over at single study visit between ages of 2-4 years inclusive
+5 more outcomes measured

Conditions

Fragile X Syndrome

Explore related trials

Fragile X Syndrome

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Elizabeth Smith, PhD
[email protected]
5135171383
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnoses of Fragile X Syndrome, Typical Development, or History of Premature Birth
able to sit independently
English is spoken at home

Exclusion

For all participants: no seizures in the past 6 months
For typical development group and Fragile X group: not born prior to 32 weeks gestation

What this trial measures

  • Change in Mullen Scales of Early Learningat single study visit between ages of 2-4 years inclusive

    change in Mullen Scales scores (age-corrected) from baseline on all subscales, including Expressive Language, Receptive Language, FIne Motor, Gross Motor, and Visual Reception. T-Scores from the Mullen Scales of Early Learning (MSEL) have a mean of 50 and a standard deviation of 10. Range=20-80. Higher scores indicate more advanced developmental skills.

  • Changes in oxygenated and deoxygenated hemoglobin concentration in response to sounds in language regions of the brainat single study visit between ages of 2-4 years inclusive

    Relative increase in oxygenated versus deoxygenated hemoglobin for no sounds, low intensity sounds, and medium intensity sounds. Measured via functional Near Infrared Spectroscopy with optodes placed over frontal, temporal, and parietal language regions.

  • Changes in amplitude of mismatch negativity response during sound discriminationat single study visit between ages of 2-4 years inclusive

    Electroencephalography is measured over the scalp while participant listens to speech sounds with infrequent "oddball" stimuli. Amplitude of the P100 for all stimuli as well as amplitude of the mismatch negativity response (frequent minus infrequent response) as well as change in these metrics over development are tracked in all groups.

  • Changes in hearing thresholdsat single study visit between ages of 2-4 years inclusive

    Hearing thresholds in dB as assessed using Conditioned Play Audiometry (CPA) or Visual Reinforced Audiometry (VRA) dependent on child age and developmental ability.

  • Otoacoustic Emissions (OAEs)at single study visit between ages of 2-4 years inclusive

    Signals produced by excitation of hair cells in cochlea are measured for a range of frequencies.

  • Changes in tympanometric pressure profile in the inner earat single study visit between ages of 2-4 years inclusive

    Wide Band Tympanometry is completed to measure variability in tympanometric pressure for left and right ears that may affect hearing profile.