NCT07798297Recruiting
Transitional Intervention for Hyperacusis in Autism
Effectiveness of an Individualized Progressive Treatment for Expanding Sound Tolerance in Adults With Autism Spectrum Disorder: A Crossover Randomized Controlled Trial (RCT)
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 24 Aug 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- University of Central Florida
- Diseases
- Autism
- NCT number
- NCT07798297
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Aug 2026 to the primary completion date, 30 Apr 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Otologic surgical procedures within the past 6 months
- Ongoing use of ototoxic medications.
- Active or past drug or alcohol dependent histories
Other illness
- 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
- Acute Meniere's disease within the past 6 months
Other
- Management for head trauma within the past 6 months
- Management for traumatic brain injury within the past 6 months
- Actively fluctuating hearing loss within the past 6 months
- Labyrinthitis within the past 6 months
- Conductive hearing loss
- Otalgia
- Known scheduling or travel conflicts
Who the study is looking for
- 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).
Age in the registry: 18 years to 39 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Callier Center for Communication Disorders Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Communication Technologies Research Center Coordinator of this site? Confirm its status | Orlando | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.