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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 month, 12 month, 18 month, 24 month, 3 year, and 4 year visits

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I can sit up by myself without help.

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I have been diagnosed with Fragile X Syndrome, or I was born prematurely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 month, 12 month, 18 month, 24 month, 3 year, and 4 year visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 month, 12 month, 18 month, 24 month, 3 year, and 4 year visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 month, 12 month, 18 month, 24 month, 3 year, and 4 year visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Mullen Scales of Early Learning

Changes in LENA vocalizations and conversational turns

Changes in amplitude of mismatch negativity response during sound discrimination

+4 more

Secondary outcome measures

Sensory Profile 2 Attentional subtest

Sensory profile 2 Auditory Processing subtest

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,471 Total Patients Enrolled

6 Trials studying Fragile X Syndrome

375 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria preclude individuals who are younger than 65 years of age?

"To join this trial, applicants must be aged 6 months to 5 years old. Additionally, there are 9 studies for participants that fall under 18 and 1 specific study targeting individuals over 65."

Answered by AI

What is the current capacity for participants in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial was first uploaded on October 4th 2022 and has been updated as recently as July 20th 2023; 120 individuals are required for this research across a single site."

Answered by AI

Are there any remaining slots available for potential participants of this medical experiment?

"This trial is actively recruiting, as per the most recent information on clinicaltrials.gov. The post detailing this study was first published on October 4th 2022 and last updated on July 20th 2023."

Answered by AI

Is self-enrollment in the research project permitted?

"Qualified applicants must be 6 months to 5 years old and have fragile x syndrome in order to gain entry into this clinical trial. Up to 120 participants will be accepted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05957549.

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