Understanding sound perception in preschoolers with Fragile X Syndrome
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Preschool Age
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 24 Months to 4 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05957549 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While studies have explored auditory processing in older children and adults with FXS, this approach focusing on preschoolers is relatively novel and untested.
Eligibility criteria
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 this trial is running
Cincinnati, Ohio
- Cincinnati Children'S Hospital — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Elizabeth Smith, PhD
- Email: elizabeth.smith3@cchmc.org
- Phone: 5135171383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.