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Recruiting
NCT07798297
Transitional Intervention for Hyperacusis in Autism
Conditions: Loudness Hyperacusis, Autism Spectrum Disorder (ASD), Hyperacusis
Sex: All
Ages: 18 Years – 39 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University of Central Florida
Location: Communication Technologies Research Center Orlando Florida
Summary
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
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
Source: ClinicalTrials.gov (NCT07798297). StuddyBuddy aggregates publicly available trial information.