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Effectiveness of an Individualized Progressive Treatment for Expanding Sound Tolerance in Adults With Autism Spectrum Disorder: A Crossover Randomized Controlled Trial (RCT)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 39
Healthy Volunteers: f
View:
• 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).
Locations
United States
Florida
Communication Technologies Research Center
NOT_YET_RECRUITING
Orlando
Texas
Callier Center for Communication Disorders
RECRUITING
Dallas
Contact Information
Primary
David A. Eddins, Ph.D.
ctrc@ucf.edu
407-823-0811
Backup
Kelly N. Jahn, Ph.D.
neuro-aud-lab@utdallas.edu
972-883-2358
Time Frame
Start Date:2026-08
Estimated Completion Date:2028-06
Participants
Target number of participants:40
Treatments
Other: Waitlist Controlled Arm
The waitlist control group, BA, will be on a waitlist for intervention for 6 months during which outcomes will be measured at monthly intervals, followed by receipt of intervention for 6 months in a manner identical to group AB.~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.
Other: Watchlist Controlled Arm
Group AB receives intervention for 6 months followed by a 6-month watchlist period during which outcomes will be measured over 6 post-intervention months.~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 hearing aid devices at an individualized level judged to be soft, but comfortable.