NCT07798297 · University of Central Florida
Transitional Intervention for Hyperacusis in Autism
(TIHA)
What this study is about
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).
View original scientific description
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.
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.
Primary outcome measures
Aided Modified Continuous Contour Test
Time frame: Baseline through study completion, an average of 1 year.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Ongoing use of ototoxic medications.
- Active or past drug or alcohol dependent histories
- Known scheduling or travel conflicts
Where
- Orlando, Florida
- Dallas, Texas
Collaborators
The University of Texas at Dallas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 1, 2026 · Source of record for eligibility and locations