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Understanding Sound Perception in Infants with Fragile X Syndrome

This study aims to understand how infants and toddlers with Fragile X Syndrome (FXS) process sounds and learn language. Researchers will use speech discrimination tasks, where two different speech sounds are played, to see how the brain responds. They will measure changes in brain activity (oxygenated and deoxygenated hemoglobin concentration) and brainwave responses (mismatch negativity) when sounds are heard. Success will be measured by changes in these brain responses and improvements in early learning skills (Mullen Scales of Early Learning) over time. The study is looking for 30 participants, including infants and toddlers aged 6 to 26 months with Fragile X Syndrome, typical development, or a history of premature birth. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 30 participants, including 15 with Fragile X Syndrome and 15 controls.
What's involved
Participants will have visits at 12, 18, and 24 months of age. During these visits, they will undergo behavioral assessments, neuroimaging (fNIRS/EEG), and hearing tests.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in early learning skills and brain responses at 12, 18, and 24 months.

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NCT06560242

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

Recruiting
NAAges 6–26InterventionalBasic science
Children's Hospital Medical Center, Cincinnati
~30 participants
Updated 2026-07-10 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 12 month, 18 month, and 24 month visits
+6 more outcomes measured

Conditions

Fragile X Syndrome

Explore related trials

Fragile X SyndromePreterm BirthTypical Development

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 12 month, 18 month, and 24 month visits

    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 12 month, 18 month, and 24 month visits

    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 12 month, 18 month, and 24 month visits

    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 12 month, 18 month, and 24 month visits

    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 12 month, 18 month, and 24 month visits

    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 12 month, 18 month, and 24 month visits

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

  • Changes in LENA vocalizations and conversational turnsat 12 month, 18 month, and 24 month visits

    LENA is a voice recording system and proprietary program that records a child's home language environment. This recording is then digitally processed to model aspects of the child's own vocalizations and those of others'.