Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05957549

Conditions

Fragile X Syndrome

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Accepted

Interventions

Speech discrimination

Study Details

Brief summary:

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.

Conditions

Fragile X Syndrome

Study ID

NCT05957549

Start date

Oct 4, 2022

Status verified date

Jul, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Speech Sounds

Participants listen to speech sounds while the investigators measure electrical and hemodynamic changes in the brain.

Interventions

Speech discrimination

Two different speech sounds are played at the same sound intensity.

Primary outcome measure

  • Change in Mullen Scales of Early Learning [ Time Frame: at single study visit between ages of 2-4 years inclusive ]
  • Changes in oxygenated and deoxygenated hemoglobin concentration in response to sounds in language regions of the brain [ Time Frame: at single study visit between ages of 2-4 years inclusive ]
  • Changes in amplitude of mismatch negativity response during sound discrimination [ Time Frame: at single study visit between ages of 2-4 years inclusive ]
  • Changes in hearing thresholds [ Time Frame: at single study visit between ages of 2-4 years inclusive ]
  • Otoacoustic Emissions (OAEs) [ Time Frame: at single study visit between ages of 2-4 years inclusive ]
  • Changes in tympanometric pressure profile in the inner ear [ Time Frame: at single study visit between ages of 2-4 years inclusive ]

Central Contacts and Locations

Central contacts

Elizabeth Smith, PhD

5135171383elizabeth.smith3@cchmc.org

Craig Erickson, MD

5136366553craig.erickson@cchmc.org

Locations

Cincinnati Children'S Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Elizabeth Smith, PhD

513-517-1383elizabeth.smith3@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jul 10, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-07-10.