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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Communication Technologies Research Center
Orlando, Florida, United States
NOT_YET_RECRUITINGCallier Center for Communication Disorders
Dallas, Texas, United States
RECRUITINGAided 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.
Time frame: Baseline through study completion, an average of 1 year.
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.
Time frame: Baseline through study completion, an average of 1 year.
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).
Time frame: Baseline through study completion, an average of 1 year.
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.
Time frame: Baseline through study completion, an average of 1 year.
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.
Time frame: Baseline through study completion, an average of 1 year.
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.
Time frame: Baseline through study completion, an average of 1 year.
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.
Time frame: Baseline through study completion, an average of 1 year.
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).
Time frame: Baseline through study completion, an average of 1 year.
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).
Time frame: Baseline through study completion, an average of 1 year.
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).
Time frame: Baseline through study completion, an average of 1 year.
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).
Time frame: Baseline through study completion, an average of 1 year.
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.
Time frame: Baseline through study completion, an average of 1 year.
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.
Time frame: End of Intervention Visit; 6 months from Baseline date for the Watchlist arm. 12 months from the Baseline date for the Waitlist arm.
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.
Time frame: Baseline through study completion, an average of 1 year.
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