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Transitional Intervention for Hyperacusis in Autism

RecruitingNAAges 18 Years - 39 YearsAllUniversity of Central Florida
NCT07798297 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The main goal of this clinical trial is to evaluate the effectiveness, benefits, and post-treatment persistence of an intervention for loudness hyperacusis in adults with autism spectrum disorder (ASD). The main questions it aims to answer are: * Does the intervention increase loudness tolerance * Does the intervention reduce symptoms related to loudness hyperacusis Researchers will compare measures related to loudness hyperacusis before, during, and after the intervention. Participants will: * Be randomly assigned to either one of two groups. One group will receiver the intervention immediately. This group will be evaluated during the 6-month intervention and evaluated for 6 months after the end of the intervention. The other group will be evaluated for 6 months before the intervention and during the 6-month intervention. * Visit the test site once every month over the course of a ye

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📋 Eligibility rules (as published)
Inclusion Criteria * Adults age 18 to 39 years * Autism spectrum disorder * Mild-to-severe loudness hyperacusis indicated by a score ≥ 22 on the Hyperacusis Questionnaire (HQ) and LDLs for tones ≤ 80 dB HL at two or more audiometric frequencies in at least one ear. * No more than slight or mild sensorineural hearing loss from 250 to 8000 Hz * Normal tympanograms consistent with normal middle ear function * Normal "tone" decay response for "comfortable but soft" broadband noise * Ability understand informed consent in English * Availability and willingness to conform to the study visit schedule * Diagnosis of autism (including Asperger's and other diagnoses "on the spectrum") * Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R) score of 65 or greater to confirm ASD diagnosis * Full-Scale IQ score of 90 or greater on the Weschler Abbreviated Scale of Intelligence (WASI-II; 2-lists). Exclusion Criteria * Management for head trauma within the past 6 months * Management for traumatic brain injury within the past 6 months * Management for epilepsy within the past 6 months * Management for seizures within the past 6 months * Management for or other neurological disorders within the past 6 months * Otologic surgical procedures within the past 6 months * Actively fluctuating hearing loss within the past 6 months * Acute Meniere's disease within the past 6 months * Labyrinthitis within the past 6 months * Conductive hearing loss * Otalgia * Ongoing use of ototoxic medications. * Active or past drug or alcohol dependent histories * Known scheduling or travel conflicts
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What it tests

  • Transitional Intervention for Hyperacusis in Autism
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Where

2 sites
Communication Technologies Research Center
Orlando, United States
Callier Center for Communication Disorders
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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