An interventional study of Speech discrimination in Fragile X Syndrome, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 6 Months to 26 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Basic science
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Among 82 studies in Fragile X Syndrome with a site in United States — 11 open to participants now, 16 under way, 2 of them phase 3. Fragile X Syndrome · United States.
Among the 82 studies in Fragile X Syndrome with a site in United States, this one is the 49th largest by planned enrollment of the 68 interventional ones that give a count, is one of 7 that started in 2022, is one of 14 with no phase, reaches primary completion later than 7 of the 15 other live ones, and was the 77th registered.
115 studies on the registry are indexed under Fragile X Syndrome; 25 are open to participants now.
Browse Fragile X Syndrome studies →11 of the 82 studies in Fragile X Syndrome with a site in United States are open now. Recruiting first, the newest first:
Healing Hope International · Sites in United States
Ages 4–12
Mirum Pharmaceuticals, Inc. · Sites in United States, Spain
Ages 13–45 · Men only
University of North Carolina, Chapel Hill · Sites in United States
Ages 18+ · Healthy volunteers
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 5–10 · Healthy volunteers
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 24 mo–4 yrs · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 18 Fragile X Syndrome studies recruiting now, 5 (28%) set no upper age limit and 13 (72%) stop at 75 or younger; 15 take children under 18; 7 take healthy volunteers.
This study: 6 Months to 26 Months · all sexes · healthy volunteers too.
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82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 36 · Phase 3 11 · Phase 4 2
First in 2002; this study’s year is marked. 7 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 54 across 92 interventional studies indexed under Fragile X Syndrome.
Median enrollment 60 across the 68 interventional studies, 100 across the 12 observational. Of the 58 that completed or were terminated, 22 (38%) have results posted.
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38 of 82 have an industry lead sponsor. The 10 most frequent:
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 129 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Children's Hospital Medical Center, Cincinnati has 8 studies filed under Fragile X Syndrome — fewer than ten, so there is no comparison to draw.
7 of the studies in Fragile X Syndrome with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05367960Phase 3Tetra Discovery PartnersAn Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome | 2027-09-30 |
| NCT03655223RTI InternationalEarly Check: Expanded Screening in Newborns | 2026-11-30 |
| NCT06139172Rush University Medical CenterWeb Intervention for Parents of Youth With Genetic Syndromes (WINGS) | 2026-12 |
| NCT06560242Children's Hospital Medical Center, CincinnatiTracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant | 2027-03-01 |
| NCT05957549Children's Hospital Medical Center, CincinnatiTracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG-Preschool Age | 2027-03-01 |
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Among the 82 studies in Fragile X Syndrome with a site in United States, from their registry updates:
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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 and toddler 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.
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 infancy 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 infants and toddlers 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 infants and toddlers, including 15 with FXS and 15 controls. Infants will complete visits at different ages, with possible visits at 6 months, 12 months, 18 months, and 24 months, so that changes with development can be tracked over time.
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Exclusion Criteria:
Participants listen to speech sounds while the investigators measure electrical and hemodynamic changes in the brain.
Other: Speech discrimination
Two different speech sounds are played at the same sound intensity.
Change in Mullen Scales of Early Learning
change in Mullen Scales scores (age-corrected) from baseline on all subscales, including Expressive Language, Receptive Language, FIne Motor, Gross Motor, and Visual Reception. T-Scores from the Mullen Scales of Early Learning (MSEL) have a mean of 50 and a standard deviation of 10. Range=20-80. Higher scores indicate more advanced developmental skills.
Time frame: at 12 month, 18 month, and 24 month visits
Changes in oxygenated and deoxygenated hemoglobin concentration in response to sounds in language regions of the brain
Relative increase in oxygenated versus deoxygenated hemoglobin for no sounds, low intensity sounds, and medium intensity sounds. Measured via functional Near Infrared Spectroscopy with optodes placed over frontal, temporal, and parietal language regions.
Time frame: at 12 month, 18 month, and 24 month visits
Changes in amplitude of mismatch negativity response during sound discrimination
Electroencephalography is measured over the scalp while participant listens to speech sounds with infrequent "oddball" stimuli. Amplitude of the P100 for all stimuli as well as amplitude of the mismatch negativity response (frequent minus infrequent response) as well as change in these metrics over development are tracked in all groups.
Time frame: at 12 month, 18 month, and 24 month visits
Changes in hearing thresholds
Hearing thresholds in dB as assessed using Conditioned Play Audiometry (CPA) or Visual Reinforced Audiometry (VRA) dependent on child age and developmental ability.
Time frame: at 12 month, 18 month, and 24 month visits
Otoacoustic Emissions (OAEs)
Signals produced by excitation of hair cells in cochlea are measured for a range of frequencies.
Time frame: at 12 month, 18 month, and 24 month visits
Changes in tympanometric pressure profile in the inner ear
Wide Band Tympanometry is completed to measure variability in tympanometric pressure for left and right ears that may affect hearing profile.
Time frame: at 12 month, 18 month, and 24 month visits
Changes in LENA vocalizations and conversational turns
LENA is a voice recording system and proprietary program that records a child's home language environment. This recording is then digitally processed to model aspects of the child's own vocalizations and those of others'.
Time frame: at 12 month, 18 month, and 24 month visits
Sensory profile 2 Auditory Processing subtest
parent-report measure of child's behavioral responses to sounds in their environment
Time frame: at 6 month, 12 month, 18 month, and 24 month visits
Sensory Profile 2 Attentional subtest
parent-report measure of child's awareness of and responses to sensory cues in their environment.
Time frame: at 6 month, 12 month, 18 month, and 24 month visits
Plan to share: Yes — Deidentified information will be shared as required for NIH grant supported studies.
Supporting information: Study protocol
No publications or documents are linked to this record.
Started Oct 2022 (actual). Primary completion is estimated for Mar 2027, 52 months after the start.
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