Transitional Intervention for Hyperacusis in Autism

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 39 Years

Healthy Volunteers

Not accepted

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.

Study Details

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

Key Dates

First listed

Sep 1, 2026

Start date

Aug 31, 2026

Status verified

Aug 2026

Primary completion

Apr 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• 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."

Primary Outcome Measure

Aided Modified Continuous Contour Test [ Time Frame: Baseline through study completion, an average of 1 year. ]

Central Contacts

• David A. Eddins, Ph.D.
  407-823-0811
  [email protected]
• Kelly N. Jahn, Ph.D.
  972-883-2358
  [email protected]

Locations (2)

Find similar trials in Orlando, FL

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