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Sound therapy may retrain the ears of adults with autism to handle loud noises

NCT ID NCT07798297

Symptom relief Sponsor: University of Central Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests a personalized program called TIHA for adults with autism who find everyday sounds painfully loud, a condition known as loudness hyperacusis. The program combines counseling, safe sound management, and gradual exposure to therapeutic sounds. Researchers will randomly assign 40 participants to start the 6-month program either immediately or after a 6-month waiting period, then track their sound tolerance and symptoms for a year. The goal is to see if the program increases comfort with loud sounds and whether the benefits last after treatment ends.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transitional Intervention for Hyperacusis in Autism (TIHA), a program combining counseling, sound management, and therapeutic sound
What this could lead to
If effective, this could offer a practical, non-drug therapy to help adults with autism tolerate everyday sounds, reducing distress and improving quality of life.
What could go wrong
This is a small early-stage trial with 40 participants, so results may not apply broadly. The intervention requires a year of monthly visits and daily practice, which may be hard to sustain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 39 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder hyperacusis Tinnitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder (ASD) Hyperacusis Loudness hyperacusis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Callier Center for Communication Disorders

    RECRUITING

    Dallas, Texas, 75235, United States

  • Communication Technologies Research Center

    NOT_YET_RECRUITING

    Orlando, Florida, 32826, United States

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