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NCT06227780 · ClinicalTrials.gov registry record · NA

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

A NA study of Autism Spectrum Disorder and Autistic Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.

Recruiting
Registry status
NA
Development phase
180
Enrollment target
1
Study location

NCT06227780: Recruiting NA study of Autism Spectrum Disorder and Autistic Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT06227780 is a NA study of Autism Spectrum Disorder and Autistic Disorder that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 180 participants, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06227780, a NA study of Autism Spectrum Disorder and Autistic Disorder, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.

RECRUITING
Registry status
NA
Development phase
180 participants
Enrollment target
1
Study location

Study Summary

Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some important discoveries have been made. Research has shown that individuals with FXS process sounds differently than those in the typical population, and they also show baseline differences in brain activity, including high gamma activity, increased theta activity, and decreased alpha activity. The investigators' central hypothesis is that these alterations in brain activity (specifically alpha and gamma activity) impair the brain's ability to process new information, thereby impeding cognitive functioning and increasing sensory sensitivity. The investigators propose that auditory entrainment, a technique that involves playing special sounds through headphones, will normalize brain activity in individuals with FXS and lead to increased cognitive function and decreased sensory hypersensitivity.

Primary Outcome

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-tr

Interventions

  • OTHER Sham
  • OTHER Alpha Auditory Entrainment

Study Locations (1)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2023-05-24
Est. Completion 2028-05-24
Phase NA

What NCT06227780 shows while recruiting

NCT06227780 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% higher).

The record links to 4 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.

NCT06227780 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT06227780 about?

NCT06227780 is a clinical study titled "Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders". Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some importa...

What is the current status of trial NCT06227780?

This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2023-05-24. Estimated completion is 2028-05-24.

What conditions does trial NCT06227780 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Autistic Disorder, Fragile X Syndrome, Asperger Syndrome.

What interventions are being tested in trial NCT06227780?

The interventions under investigation include: Sham (OTHER), Alpha Auditory Entrainment (OTHER).

Who is sponsoring clinical trial NCT06227780?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06227780 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Autism Spectrum Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06227780's enrollment target sits among peer trials

180 47th of 224 higher than 176 of 224 other Autism Spectrum Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06227780, the US trial registry maintained by the National Library of Medicine. NCT06227780 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.