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Speech Discrimination Assessments for Fragile X Syndrome

N/A
Recruiting
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to sit independently
Diagnoses of Fragile X Syndrome, Typical Development, or History of Premature Birth
Must not have
No seizures in the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at single study visit between ages of 2-4 years inclusive
Awards & highlights
No Placebo-Only Group

Summary

This trial explores how Fragile X Syndrome affects speech and hearing in children, using behavioral assessments, neuroimaging, and hearing tests.

Who is the study for?
This trial is for children who have Fragile X Syndrome, can sit by themselves, and come from homes where English is spoken. It's also open to those with typical development or a history of premature birth. Children who've had seizures in the last six months or were born before 36 weeks (except for preemies) cannot participate.
What is being tested?
The study investigates how kids with Fragile X Syndrome process sounds and learn speech. It involves behavioral assessments, brain imaging (fNIRS/EEG), and hearing tests to compare their abilities with typically developing children.
What are the potential side effects?
There are no direct side effects mentioned as this trial focuses on non-invasive assessments like neuroimaging and hearing tests rather than medication or surgical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can sit up by myself without help.
Select...
I have been diagnosed with Fragile X Syndrome, or I was born prematurely.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had a seizure in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at single study visit between ages of 2-4 years inclusive
This trial's timeline: 3 weeks for screening, Varies for treatment, and at single study visit between ages of 2-4 years inclusive for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Mullen Scales of Early Learning
Changes in amplitude of mismatch negativity response during sound discrimination
Changes in hearing thresholds
+3 more
Secondary study objectives
Sensory Profile 2 Attentional subtest
Sensory profile 2 Auditory Processing subtest

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Speech SoundsExperimental Treatment1 Intervention
Participants listen to speech sounds while the investigators measure electrical and hemodynamic changes in the brain.

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
837 Previous Clinical Trials
6,565,247 Total Patients Enrolled
7 Trials studying Fragile X Syndrome
405 Patients Enrolled for Fragile X Syndrome

Media Library

Speech Sounds Clinical Trial Eligibility Overview. Trial Name: NCT05957549 — N/A
Fragile X Syndrome Research Study Groups: Speech Sounds
Fragile X Syndrome Clinical Trial 2023: Speech Sounds Highlights & Side Effects. Trial Name: NCT05957549 — N/A
Speech Sounds 2023 Treatment Timeline for Medical Study. Trial Name: NCT05957549 — N/A
~24 spots leftby Aug 2025
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