Transitional Intervention for Hyperacusis in Autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial tests a transitional intervention designed to shift individuals with autism from heavy sound avoidance to active exposure therapy to improve loudness tolerance. Participants with mild-to-severe loudness hyperacusis and ASD are randomized to receive the intervention immediately or after a delay, with daily diary tracking and monthly clinical visits over 12 months. Outcomes focus on changes in loudness tolerance and hyperacusis-related symptoms measured before, during, and after treatment. The study includes adults ages 18–39 with specific audiometric and cognitive criteria and excludes recent head trauma or other limiting conditions. Conducted at two U.S. centers, the trial aims to establish feasibility and potential benefit of this approach for ASD-related hyperacusis.

Why it matters

Who can join: the full rules

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

Where it's running

• Callier Center for Communication Disorders
  Dallas, Texas, United States Recruiting
• Communication Technologies Research Center
  Orlando, Florida, United States Not yet recruiting

Study contacts

• Principal investigator: David A. Eddins, Ph.D. — University of Central Florida
• Study coordinator: David A. Eddins, Ph.D.
• Email: ctrc@ucf.edu
• Phone: 407-823-0811

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Clown therapy to help kids with autism sit for dental visits

  This study tests whether clown therapy can help children with autism sit through a dental examination more easily than conventional familiarization methods.

  Recruiting University of Milan · Milan, Milan · NCT07906288

• French Minds: a French, Multimodal Cohort Study of Severe Psychiatric Disorders and Healthy Controls

  This study tests whether people with mood, psychotic, or autism disorders can be grouped into more similar subtypes based on social withdrawal and anhedonia, across ages 15 to 60.

  Recruiting at 10 sites Fondation FondaMental · Besançon and 16 other locations · NCT07881016

• Cardiorespiratory and muscular fitness in children with obesity and autism

  This study tests whether cardiorespiratory fitness and handgrip strength differ between children with obesity who have autism and those who do not, and how these fitness measures relate to body size, composition, and cardiometabolic health.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT07804680

• Museum visits to support social and emotional well‑being in autistic adults

  This study tests whether visiting the National Taiwan Museum can help improve social participation and well-being for autistic adults aged 18–50.

  Recruiting National Taiwan University Hospital · Taipei · NCT07768332

• AdiaVita and glutathione for autism in kids and teens

  This study tests whether adding AdiaVita (cord-blood stem cells and exosomes) to glutathione helps improve ASD symptoms in children and other participants compared with glutathione alone.

  Recruiting at 2 sites Phase 1 Greater Atlanta Integrative Pediatrics · Roswell, Georgia and 1 other locations · NCT07622316

• Online test of BlinkLab Dx1 for autism in kids aged 2–11

  This study tests whether the BlinkLab Dx1 smartphone app can help identify autism in children aged 2 to 11 by comparing app-based measurements with prior clinical diagnoses.

  Recruiting Blinklab Limited · Princeton, New Jersey · NCT07590973

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.