Transitional Intervention for Hyperacusis in Autism

NCT07798297 | Recruiting FDA Device

• 2 other identifiers: AR240252HT9425-25-1-0318
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Autism Spectrum Disorder (ASD); Hyperacusis; Loudness Hyperacusis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Aided Modified Continuous Contour Test

  Sound intensity (dB SPL) corresponding to a judgment of "loud, but okay" for continuous speech as measured in the modified continuous contour test (Aided MCCT) during aided listening (i.e., while wearing study hearing aid devices) in the test ear (TE). In this trial, the TE is the participant's ear with the poorest pre-treatment sound tolerance. This measure was chosen to maximize validity, reliability, and utility relative to available alternative outcomes. The continuous speech stimulus used to evaluate loudness perception is a 16-second passage known as the "Carrot Story" that is spoken by a female talker with neutral accent and widely used in hearing aid prescriptive fittings. The passage features a broad sampling of the speech sounds in the English language and has a long-term average spectral shape (LTASS) that matches average vocal effort. The passage is delivered in sound field via the loudspeaker built into a clinical hearing instrument test system.

  Baseline through study completion, an average of 1 year.

Secondary Outcomes (13)

• Hyperacusis Questionnaire

  Baseline through study completion, an average of 1 year.

• Questionnaire on Hypersensitivity to Sound (GÜF)

  Baseline through study completion, an average of 1 year.

• Tampa Scale of Hyperacusis

  Baseline through study completion, an average of 1 year.

• Tinnitus Questionnaire

  Baseline through study completion, an average of 1 year.

• Noise Avoidance Questionnaire

  Baseline through study completion, an average of 1 year.

Study Arms (2)

Waitlist Controlled Arm

OTHER

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: Transitional Intervention for Hyperacusis in Autism

Watchlist Controlled Arm

OTHER

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."

Other: Transitional Intervention for Hyperacusis in Autism

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.

Waitlist Controlled Arm; Watchlist Controlled Arm

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Florida: lead
• The University of Texas at Dallas: collaborator

Study Sites (2)

Communication Technologies Research Center

Orlando, Florida, 32826, United States

NOT YET RECRUITING

Callier Center for Communication Disorders

Dallas, Texas, 75235, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Hyperacusis; Autistic Disorder; Tinnitus

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David A. Eddins, Ph.D.

  University of Central Florida

  PRINCIPAL INVESTIGATOR

• Kelly N. Jahn, Ph.D.

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A. Eddins, Ph.D.

CONTACT

407-823-0811; ctrc@ucf.edu

Kelly N. Jahn, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The clinical trial model consists of a randomized, within-person, repeated-measures, waitlist-controlled full crossover design adhering to an intent-to-treat analysis.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 1, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)