Clinical trial Recruiting at 1 site Interventional Ages 6 Months to 26 Months

Understanding sound perception in infants with Fragile X Syndrome

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

Run by Children's Hospital Medical Center, Cincinnati · NCT06560242 · Data updated 2026-11-12

This study tests how infants and toddlers with Fragile X Syndrome hear and understand sounds compared to other children to help identify early signs of language delays.

Quick facts

Study typeInterventional
Ages6 Months to 26 Months
SexAll
Enrollment30 (estimated)
SponsorChildren's Hospital Medical Center, Cincinnati
Academic / other
Locations1 site (Cincinnati, Ohio)
StatusRecruiting
StartedOctober 31, 2022
Main results expectedMarch 1, 2027
Study endsMarch 1, 2027
Registry record updatedJuly 10, 2026
Trial IDNCT06560242 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include infants and toddlers diagnosed with Fragile X Syndrome, those with typical development, or those with a history of premature birth who can sit independently and speak English at home.

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 infants and toddlers with Fragile X Syndrome (FXS) perceive sound and language compared to typically developing children. 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 this population. The study will track 30 infants over time, assessing their responses to various auditory stimuli at different developmental stages. By focusing on the neural mechanisms underlying sound perception, the study seeks to enhance understanding of language delays associated with FXS.

Why it matters

Potential benefit: If successful, this study 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 sound perception in older children and adults with FXS, this approach focusing on infants is novel and has not been extensively tested.

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.