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Transitional Intervention for Hyperacusis in Autism

Sponsor: University of Central Florida • ClinicalTrials.gov ID: NCT07798297

Registry updated: 2026-09-01

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Description

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 year for evaluation and intervention activities * Keep a diary of their symptoms and the number of hours per day they engage in the intervention

Interventions

Transitional Intervention for Hyperacusis in Autism (Other)
The TIHA consists of three components: 1) structured counseling, 2) protective sound management, and 3) therapeutic sound. Structured counseling is to prepare the participant to transition from their current state, which most often involves counterproductive overuse of hearing protection devices and corresponding self-imposed sound isolation. Protective sound management limits exposure to sounds that are too loud for the individual participant while promoting and maximizing healthy exposure to safe and comfortable sound levels. This is achieved through custom fitting of the intervention hearing aid devices. Active sound therapy consists of soft, "seashell" - like noise delivered by the intervention devices at an individualized soft but comfortable level.

Eligibility criteria

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

Conditions

Loudness Hyperacusis Autism Spectrum Disorder (ASD) Hyperacusis

Locations

Communication Technologies Research Center — Orlando, Florida, United States
Callier Center for Communication Disorders — Dallas, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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