ClinicalTrials.gov record NCT05957549

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age2 years old to 4 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This study measures how preschool children with Fragile X Syndrome process sounds and speech. Children (ages 2–4) attend a single study visit for developmental testing, hearing tests, parent questionnaires, and to listen to sounds while EEG and functional near-infrared spectroscopy (fNIRS) record brain responses. The study includes comparison groups of typically developing children and children born prematurely with language delays.

What it is studying. How brain electrical signals and blood-oxygen changes respond to speech and nonspeech sounds in preschoolers with Fragile X, and how those responses compare with two control groups.

What the researchers hope to learn. To quantify and localize auditory hypersensitivity and neural differentiation in preschoolers with Fragile X Syndrome, and to assess whether these brain response patterns differ from typically developing children and from children born prematurely with language delays. The study aims to identify early brain-based measures related to speech and hearing differences in FXS.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Individuals with Fragile X Syndrome show differences in how they understand and learn language from infancy. They frequently have lifelong delays in speech and language as well. In addition, they experience other auditory symptoms, including being very sensitive to certain sounds as well as being more sensitive than others to loud sounds. The underlying brain activity for sound perception and speech learning in Fragile X is not well understood, especially in the infant, toddler, and preschool years. This study uses behavioral assessment of speech and language abilities, neuroimaging, and hearing tests to understand how speech and hearing are different in children with Fragile X Syndrome.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Speech discrimination

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Fragile X Syndrome (FXS) is the leading monogenic cause of intellectual disability and autism and is associated with extremely high risk for early delays in speech and language. While early childhood is essential for speech and language development, neural mechanisms for language impairments have been studied entirely in older children and adults with FXS. Therefore, markers for speech and language impairments are unavailable in young children with FXS to predict severity, test potential mechanisms, and track response to intervention. The investigators have identified a hallmark brain-based phenotype of hyperresponsiveness to sounds in adolescents and adults with FXS. This fundamental alteration in cortical responses to sound could influence early language delays, but this phenotype has not been explored in infants or toddlers with FXS. Specifically, in this study the investigators will use simultaneous EEG/fNIRS during presentation of simple speech, stories, and nonspeech sounds to quantify and localize auditory hypersensitivity and neural differentiation in 30 preschoolers with FXS. The investigators will assess specificity through comparison with 30 typically developing controls and 30 mental-age matched children with a history of premature birth and language delays.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participation is a single study visit (for children aged 2–4) that includes behavioral testing of speech and development and parent questionnaires. Your child will listen to speech, stories, and nonspeech sounds while investigators record brain electrical activity (EEG) and blood-oxygen responses in language areas using simultaneous fNIRS. The visit also includes hearing tests (conditioned play audiometry or visual reinforced audiometry depending on age/development), otoacoustic emissions, and wideband tympanometry; all assessments are completed during that single visit.

How the study is structured. Interventional basic-science study in a single-group, non-masked design. Each participant completes one study visit during which they listen to speech, stories, and nonspeech sounds while simultaneous EEG (electrical activity) and fNIRS (blood-oxygen changes) are recorded. Investigators also perform hearing checks (including otoacoustic emissions and tympanometry), developmental testing (Mullen Scales of Early Learning), and collect parent-report questionnaires. All participants receive the same testing procedures.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on fragile X syndrome

Clinical trials20 trials listed for fragile X syndromeEvery trial the registry lists for fragile X syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in fragile X syndrome researchLatest monthly update: September 2026. Includes: Multiple behavior challenges. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 4, 2022
Primary completion
Mar 1, 2027 (estimated)
Study completion
Mar 1, 2027 (estimated)
Target enrollment
90 participants (estimated)
Last updated on registry
Jul 10, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Children's Hospital Medical Center, Cincinnati

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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