Recruiting

Intervention for Hyperacusis

Sponsor:

University of Central Florida

Code:

NCT07798297

Conditions

Loudness Hyperacusis

Autism Spectrum Disorder (ASD)

Hyperacusis

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

Transitional Intervention for Hyperacusis in Autism

Study Details

Brief 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

Study ID

NCT07798297

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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."

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

David A. Eddins, Ph.D.

407-823-0811ctrc@ucf.edu

Kelly N. Jahn, Ph.D.

972-883-2358neuro-aud-lab@utdallas.edu

Locations

Callier Center for Communication Disorders

Recruiting

Dallas, Texas, United States, 75235

Contacts

Kelly N Jahn, Ph.D.

972-883-2358neuro-aud-lab@utdallas.edu

Study Lead

972-883-2358neuro-aud-lab@utdallas.edu

More Information

Sponsor

University of Central Florida

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • hyperacusis
  • sound sensitivity disorder
  • autism
  • tinnitus
  • hearing
  • decreased sound tolerance
  • hearing protection
  • earplugs
  • counseling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Central Florida on 2026-09-01.