Clinical trial Recruiting at 1 site Interventional Ages 24 Months to 4

Understanding sound perception in preschoolers with Fragile X Syndrome

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

Run by Children's Hospital Medical Center, Cincinnati · NCT05957549 · Data updated 2026-11-12

This study is trying to see how preschoolers with Fragile X Syndrome hear and understand sounds and language compared to other kids, to help identify early signs of speech and language challenges.

More Fragile X Syndrome trials

Quick facts

Study typeInterventional
Ages24 Months to 4 Years
SexAll
Enrollment90 (estimated)
SponsorChildren's Hospital Medical Center, Cincinnati
Academic / other
Locations1 site (Cincinnati, Ohio)
StatusRecruiting
StartedOctober 4, 2022
Main results expectedMarch 1, 2027
Study endsMarch 1, 2027
Registry record updatedJuly 10, 2025
Trial IDNCT05957549 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are preschool-aged children diagnosed with Fragile X Syndrome, typically developing children, or those with a history of premature birth.

Probably not a fit

Patients who have experienced seizures in the past six months or were born before 32 weeks gestation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how children with Fragile X Syndrome (FXS) perceive sound and language compared to typically developing peers. Using a combination of behavioral assessments, neuroimaging techniques like EEG and fNIRS, and hearing tests, the research aims to identify early markers of speech and language impairments in preschool-aged children with FXS. By comparing responses to sounds in children with FXS to those of typically developing children and those with a history of premature birth, the study seeks to uncover the neural mechanisms underlying auditory hypersensitivity and its impact on language development.

Why it matters

Potential benefit: If successful, this research could lead to early identification and intervention strategies for speech and language delays in children with Fragile X Syndrome.

How similar studies have gone: While studies have explored auditory processing in older children and adults with FXS, this approach focusing on preschoolers is relatively novel and untested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* 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

Where it's running

  • Cincinnati Children'S Hospital
    Cincinnati, Ohio, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.