Understanding sound perception in infants with Fragile X Syndrome
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Months to 26 Months |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06560242 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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 study 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 sound perception in older children and adults with FXS, this approach focusing on infants is novel and has not been extensively tested.
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.