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 type | Interventional |
|---|---|
| Ages | 6 Months to 26 Months |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | October 31, 2022 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT06560242 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
- Study coordinator: Elizabeth Smith, PhD
- Email: elizabeth.smith3@cchmc.org
- Phone: 5135171383
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CTH120 in Fragile X syndrome: safety and early effectiveness in adult males
This study tests CTH120 versus placebo to see if it is safe and helps adults with Fragile X syndrome.
-
MRM-3379 for males with Fragile X Syndrome (BLOOM)
This trial will test three doses of the oral drug MRM-3379 in males with Fragile X Syndrome aged 16–45 (placebo-controlled), with a parallel open-label group for ages 13–15.
-
Inclusive physical activity program for adults with intellectual disabilities
This study is testing a new fitness program for adults with intellectual disabilities to see if it helps them be more active and feel better over 16 weeks.
-
Cannabidiol for Anxiety and GABA Function in Fragile X Syndrome
This study tests a cannabidiol oral solution to see if it helps anxiety and brain signaling in people with Fragile X syndrome.
-
Using sound to improve cognitive function and sensory sensitivity in youth with developmental disorders
This study is testing if listening to special sounds can help improve thinking skills and reduce sensitivity to noise in children with Fragile X Syndrome and Autism Spectrum Disorder.
-
Non-invasive prenatal diagnosis for single gene disorders
This study is testing a new way to safely diagnose single-gene disorders in unborn babies using a simple blood test from the mother, starting as early as 9 weeks into the pregnancy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.