About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Transitional Intervention for Hyperacusis in Autism
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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).
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.
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.
Sponsors and contacts
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University of Central Florida
Lead sponsor
The University of Texas at Dallas
Collaborator