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Loudness HyperacusisTIHANCT07798297

Transitional Intervention for Hyperacusis in Autism

A study testing Transitional Intervention for Hyperacusis in Autism in people with Loudness Hyperacusis and Autism Spectrum Disorder (ASD), run by University of Central Florida at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 39 years
What is being tested?
Transitional Intervention for Hyperacusis in Autism
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
Aug 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States2 sites, 2 recruiting
  • Callier Center for Communication Disorders

    Dallas, Texas, 75235

    Kelly N Jahn, Ph.D., 972-883-2358, neuro-aud-lab@utdallas.edu

    Study Lead, 972-883-2358, neuro-aud-lab@utdallas.edu

    Recruiting
  • Communication Technologies Research Center

    Orlando, Florida, 32826

    David A. Eddins, Ph.D., 407-823-0811, ctrc@ucf.edu

    Study Lead, 407-823-3172, ctrc@ucf.edu

    Not yet recruiting

Other trials in United States

About this study

Official title: Effectiveness of an Individualized Progressive Treatment for Expanding Sound Tolerance in Adults With Autism Spectrum Disorder: A Crossover Randomized Controlled Trial (RCT)

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.
Read more

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
Read the detailed description

Background: Loudness hyperacusis, "an unusual intolerance to the loudness of ordinary environmental sounds," is a core feature of autism spectrum disorder (ASD) as recognized by the American Psychiatric Association. Loudness hyperacusis affects 37 to 46% of autistic people, yet despite this pervasiveness, there is no standard treatment and the evidence supporting existing treatments is low. The lack of effective treatment is consistent with weak evidence for successful interventions for other sensory deficits associated with ASD. Combined with sound-related discomfort, annoyance, anxiety, fear, and even pain, loudness hyperacusis can have life-altering effects impacting social well-being, employment, healthcare seeking behaviors, and risk of self-harm. The presence of ASD compounds the risk for such consequences. Recognizing these impacts, autistic people indicate that development of hyperacusis treatments is a top priority for autism research.

Objectives: The objective of this intervention is to address the problem of LH in ASD by transitioning individuals from their typical counterproductive sound avoidance behaviors (i.e., overuse of sound-attenuating hearing protection devices and self-imposed limited exposure to healthy low-level sounds) into beneficial sound therapy treatment that can expand their dynamic range for sound intensity to the point where they can tolerate everyday sounds and experience an improved quality of life. A similar intervention, which combines structured counseling, protective sound management, and sound therapy has succeeded in significantly expanding the dynamic range of hearing for non-autistic adults with LH.

Hypothesis: It has been proposed that enhanced neural gain in the central auditory pathway is responsible for loudness hyperacusis (LH) in individuals with ASD. Therefore, we hypothesize that our transitional intervention for hyperacusis in autism (TIHA) will: (1) expand the dynamic range for sound intensity in individuals with ASD and (2) reduce or suppress the enhanced central gain associated with LH.

Specific Aim: The specific aim of this clinical trial is to evaluate the effectiveness, benefits, and post-treatment persistence of an intervention for LH in adults, ages 18 to 39 years, with ASD, normal intelligence, and a primary auditory complaint of mild-to-severe LH.

Study Design: This multi-site (University of Central Florida, University of Texas at Dallas) trial will enroll 40 autistic adults with mild-to-severe hyperacusis, as indicated by a score ≥ 22 on the Hyperacusis Questionnaire (HQ) and LDLs for tones ≤ 80 dB HL at two or more audiometric frequencies. In the randomized, within-person, repeated-measures, waitlist-controlled full crossover design, participants will be randomized into one of two groups. Group AB receives the 6-month intervention followed by a 6-month "watchlist" period. Group B begins in the 6-month waitlist control period followed by the 6-month intervention. Primary and secondary outcomes will be measured monthly and evaluated in an intention-to-treat analysis of all available data.

Clinical Impact: With high prevalence and associated risks, the impact of untreated LH in ASD can be severely debilitating and life altering. Transitioning this population out of counterproductive sound avoidance behaviors by expanding their dynamic range for sound intensity can enhance social engagement, expand the set of routinely sampled environments, and open learning, recreational, and vocational opportunities not currently available because of decreased sound tolerance. Following successful completion of this clinical trial, much needed information about treatment dynamics and maintenance dosing will be available to guide subsequent research and clinical applications of the intervention concepts and principles for other hyperacusic individuals with ASD, including children and those adults with more severe and complex involvement. Potential benefits include reduced or eliminated counterproductive sound-triggered behaviors and increased attention, focus, and pleasure associated with daily activities limited by decreased sound tolerance. Ultimately, the benefits of a successful intervention and the findings from this completed trial will steepen learning and treatment trajectories while providing new and improved opportunities for the trial participants in their pursuit of employment, social opportunities that increase quality of life, and economic prosperity. Ultimately, these benefits, together with improved mental health outcomes subsequent to the elimination of barriers to routine healthy sound exposures, can be expected to enhance the enjoyment of life for virtually all autistic people affected by hyperacusis.

Being tested
Transitional Intervention for Hyperacusis in Autism
Keywords
hyperacusis, sound sensitivity disorder, autism, tinnitus, hearing, decreased sound tolerance, hearing protection, earplugs, counseling
Medical subject headings
Autism Spectrum Disorder, Hyperacusis, Autistic Disorder, Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transitional Intervention for Hyperacusis in AutismOther

    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.

Study groups in NCT07798297
Study groupRoleWhat they receive
Waitlist Controlled ArmOtherThe 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.
Receives: Other: Transitional Intervention for Hyperacusis in Autism
Watchlist Controlled ArmOtherGroup 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."
Receives: Other: Transitional Intervention for Hyperacusis in Autism

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline through study completion, an average of 1 year.

Secondary outcomes (13)
  1. Hyperacusis Questionnaire

    The Hyperacusis Questionnaire is one of the earliest developed and most widely reported subjective tools for assessing supra-threshold auditory hypersensitivity in adults. It has been used both as a screening tool for hyperacusis and as an outcome measure of treatment-related change in hyperacusis severity. The HQ contains 14 items, each rated on a 4-point Likert scale with scores ranging from 0 (no) to 3 (yes, a lot). The total scoring range spans from 0 to 42 with attentional, social, and emotional subscales. Aazh and Moore (2017) proposed an HQ global score ≥ 22 as a cutoff indicator of a LH condition, with greater scores indicative of a greater problem.

    Measured: Baseline through study completion, an average of 1 year.

  2. Questionnaire on Hypersensitivity to Sound (GÜF)

    The GÜF is a tool developed and validated in adult tinnitus patients. In this study, we will use the translation of the questionnaire from the original German to English. The GÜF was designed to evaluate subjective distress and annoyance associated with hypersensitivity to sound using 16 items, each rated on a 4-point Likert scale with scores ranging from 0 (never correct) to 3 (always correct). The GÜF total score range spans from 0 to 45, with four levels of distress (mild to severe) and three subscales (cognitive reactions to hyperacusis; actional/somatic behavior; and emotional reaction to external noises).

    Measured: Baseline through study completion, an average of 1 year.

  3. Tampa Scale of Hyperacusis

    The Tampa Scale of Hyperacusis is an English version of the Tampa Scale for Kinesiophobia modified for Hyperacusis. The questionnaire was originally developed as a 17-item index of excessive, irrational, and debilitating fear of movement, physical activity, and fear avoidance related to (re)injury in chronic pain patients with musculoskeletal disorders. It was adapted for use as a subjective tool to assess pain of suffering due to sound exposure in adults. We have translated their Swedish version for use with English-speaking hyperacusis patients. It has 17-items and uses a 4-point response scale with scores ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores indicate hyperacusis of greater severity; the cutoff for a clinically meaningful condition is ≥ 37.

    Measured: Baseline through study completion, an average of 1 year.

  4. Tinnitus Questionnaire

    The Tinnitus Questionnaire is a 52-item questionnaire designed to establish tinnitus severity, a condition that is highly co-morbid with Loudness Hyperacusis. It consists of 52 items scored on a three-point Likert scale (0, 1, 2). The questions are grouped into five subscales: psychological distress, intrusiveness, hearing difficulties, sleep disturbances, and somatic complaints. This was the primary outcome measure in our successful Phase III NIH-sponsored clinical trial that investigated the efficacy of Tinnitus Retraining Therapy. The TQ was chosen for its excellent validity and generalizability properties. Higher TQ scores indicate greater tinnitus severity.

    Measured: Baseline through study completion, an average of 1 year.

  5. Noise Avoidance Questionnaire

    The Noise Avoidance Questionnaire assesses the avoidance of sound in daily life and those events and places avoided. The first 15 of the 25 items address avoidance behaviors using the introductory phrase "In order to expose myself to no or less noise…."; the remaining 10 items, 16 to 25, address the events and places avoided using the introductory phrase "In order to expose myself to no or less noise I avoid…". Each item is ranked on a 5-point Likert scale with scores ranging from 0 (never) to 4 (very often/always). Scores range from 0 to 100, with a higher score indicating a greater sound- or noise-related avoidance problem.

    Measured: Baseline through study completion, an average of 1 year.

  6. Weinstein Noise Sensitivity Scale (WNSS-21)

    The Weinstein Noise Sensitivity Scale (WNSS-21) is designed to measure one's sensitivity to noise based on self-report. It consists of 21 items that probe reactions and attitudes related to environmental sounds encountered in everyday life. Items are scored on a 6-point Likert scale ranging from 0 (strong disagreement) to 5 (strong agreement). Total score ranges from 0 to 105 with a higher score indicating greater sensitivity to noise.

    Measured: Baseline through study completion, an average of 1 year.

  7. Duke-Vanderbilt Misophonia Screening Questionnaire (DVMSQ)

    The Duke-Vanderbilt Misophonia Screening Questionnaire (DVMSQ) is a self-report measure of symptoms associated with misophonia (i.e., strong dislike, hatred, or annoyance of certain sounds). It consists of 19 items that reflect diagnostic criteria and takes into consideration definitions of misophonia. The first screening question evokes a "yes or "no" response. The second item is open-ended and allows the respondent to list sounds that are extremely bothersome, even when they are soft. Responses to the next 18 items are on a five-point Likert scale ranging from 0 (never) to 4 (very often). Scoring options include a total score (0 to 68, used in this trial), a symptom score (0 to 40), and an impairment score (0 to 28).

    Measured: Baseline through study completion, an average of 1 year.

  8. DSM-5 Phonophobia Severity Scale

    The DSM-5 Phonophobia Severity Scale is based on the DSM-5 Specific Phobia Severity Scale that has been modified for phonophobia. Specifically, the phrase prior to each question has been modified to read "Over the past seven days, how often have you experienced the following regarding situations when you are exposed to loud or unpleasant sounds? During the past 7 days I have:" This preamble is followed by 10 questions scored on a 5-point Likert scale ranging from 0 (never) to 4 (all of the time).

    Measured: Baseline through study completion, an average of 1 year.

  9. PROMIS Global-10

    The PROMIS Global-10 quality of life questionnaire (PROMIS 10) is a 10-item tool commonly used in autism research with well-established psychometric properties and a simple software scoring system . Developed under the NIH PROMIS Initiative, the PROMIS-10 probes overall quality of life with sub-domains focused on physical and mental health, physical functioning, satisfaction and ability to carry out social activities, emotional distress, pain, and fatigue. The instrument has been tested and validated with adults and in several clinical populations including ASD. Scoring supports separate analyses of individual items as well as global physical health and global mental health domain scores. Quality of life is interpreted in terms of T-scores parsed into five categories (1) Poor (T-score <33.5), (2) Fair (T-score between 33.5 and 43.3), (3) Good (T-score between 43.4 and 53.3), (Very good (T-score between 53.4 and 64.5), and (5) Excellent (T-score >64.5).

    Measured: Baseline through study completion, an average of 1 year.

  10. Social Responsiveness Scale-2 (SRS-2)

    The Social Responsiveness Scale-2 (SRS-2) was designed to measure the severity of autism symptoms and consists of 65 items parsed into five content areas: social awareness, social cognition, social communication, social motivation, and restricted interests and repetitive behavior. The instrument has been validated for use with adults. The SRS-2 domain scores include four categories: Within normal limits (≤ 49), Mild (60 to 65), Moderate (66 to 75), and Severe (≥ 76).

    Measured: Baseline through study completion, an average of 1 year.

  11. Short Sensory Profile 2 (SSP-2)

    The Short Sensory Profile 2 (SSP-2) is a widely used instrument designed to classify the degree of sensory abnormality. It consists of 38 items broken into seven sensitivity subscales: tactile, taste/smell, movement, under-responsive/seeks sensation, auditory filtering, low energy/weak, and visual/auditory sensitivity.

    Measured: Baseline through study completion, an average of 1 year.

  12. End of Intervention Survey

    The End of Intervention Survey is begins with an overview of the three components followed by 25 questions evaluating perceptions of potential strengths and weaknesses of the study components along with questions that would support computation of a net promoter score.

    Measured: End of Intervention Visit; 6 months from Baseline date for the Watchlist arm. 12 months from the Baseline date for the Waitlist arm.

  13. EFR Growth Function

    The EFR (Envelope Following Response) Growth Function is an index computed from an electroencephalography (EEG) recording designed as an objective measure to assess the change in neural response as sound level increases from low-to-high in a manner that is analogous to behavioral loudness growth tasks such as the Contour Test. By slowly increasing the intensity of the stimulus and adjusting the sound levels according to the participant's unique comfort levels, the protocol is designed to avoid causing discomfort while maximizing the amount of data acquired across the auditory dynamic range.

    Measured: Baseline through study completion, an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionApr 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
The clinical trial model consists of a randomized, within-person, repeated-measures, waitlist-controlled full crossover design adhering to an intent-to-treat analysis.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07798297
Sponsor's protocol ID
AR240252
Other IDs
HT9425-25-1-0318
Acronym
TIHA
Status last verified
Aug 2026
First submitted
24 Aug 2026
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transitional Intervention for Hyperacusis in Autism in people with Loudness Hyperacusis and Autism Spectrum Disorder (ASD), run by University of Central Florida at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David A. Eddins, Ph.D. (407-823-0811, ctrc@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aided Modified Continuous Contour Test (time frame: Baseline through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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