Back to search results

Alpha Auditory Entrainment for Fragile X Syndrome and Autism

This study is exploring a new way to help young people with Fragile X Syndrome (FXS) or Autism Spectrum Disorder (ASD) by using sound. It's testing if "Alpha Auditory Entrainment" (AAE), which involves listening to specific sound frequencies through headphones or speakers, can improve learning and reduce sensory sensitivities. Researchers believe that individuals with FXS process sounds differently and have different brain activity, and that AAE might help improve how their brains detect signals. You could be eligible if you are 5 to 10 years old and have a confirmed diagnosis of FXS (with a specific genetic mutation) or ASD (with no known genetic mutation and a low score on the SCQ screen). The study aims to see if AAE improves your "Word Learning Index" after one week compared to a "Sham" (placebo) sound. The study plans to enroll 180 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 180 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 1 week after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06227780

Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders

Recruiting
NAAges 5–10InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~180 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Alpha Auditory EntrainmentSham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Alpha auditory entrainment versus sham effect on Word Learning Index during the Statistical Learning Passive Task.
Measured over 1 week

Conditions

Fragile X Syndrome
Autism Spectrum Disorder
Autistic Disorder
Asperger Syndrome

Explore related trials

Autism Spectrum DisorderFragile X SyndromeFMR1 Gene

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Ernest V Pedapati, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Jae Citarella
[email protected]
513-636-0875
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

FXS Cohort: 1) Aged 5-10 years, inclusive; 2) Patient has full FMR1 mutation confirmed by genetic testing.
ASD Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator.
TDC Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator; 6) Patient has met normal developmental milestones; Patient has no family history of heritable neuropsychiatric disorders; 7) Patient has an IQ greater than 85 on the Stanford-Binet; 8) Score ≤8 on an SCQ screen.

Exclusion

All subjects: 1) Patient has auditory or visual impairments that cannot be corrected; 2) History of substance abuse or dependence within the past 6 months

What this trial measures

  • Alpha auditory entrainment versus sham effect on Word Learning Index during the Statistical Learning Passive Task.1 week

    The Statistical Learning Passive Task uses an EEG-based measure of neural entrainment that uses inter-trial coherence (ITC) to calculate Word Learning Index (WLI). Patterns of EEG phase-locking, corresponding to a shift in processing from raw syllable units to cohesive words, reflect gradual statistical learning in the brain. The WLI effect can be quantified by creating a ratio of the inter-trail coherence for words versus syllables, as follows: WLI = Inter-trial Coherence word rate / Inter-trial Coherence syllable rate A higher WLI indicates a relatively stronger response to tri-syllabic nonwords compared to raw syllables, reflecting stronger word segmentation due to statistical learning.