Transitional Intervention for Hyperacusis in Autism

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

Conditions

• Loudness Hyperacusis
• Autism Spectrum Disorder (ASD)
• Hyperacusis

Interventions

OTHER

Transitional Intervention for Hyperacusis in Autism

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.

Sponsors & Collaborators

• The University of Texas at Dallas

  collaborator OTHER

• University of Central Florida

  lead OTHER

Principal Investigators

• David A. Eddins, Ph.D. · University of Central Florida

• Kelly N. Jahn, Ph.D. · The University of Texas at Dallas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2028-04-30

Completion

2028-06-30

FDA Device

Yes

Countries

• United States

Study Locations