Effectiveness of an Individualized Progressive Treatment for Expanding Sound Tolerance in Adults With Autism Spectrum Disorder: A Crossover Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Aided Modified Continuous Contour Test
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
- •Ongoing use of ototoxic medications.
- •Active or past drug or alcohol dependent histories
- •Known scheduling or travel conflicts
研究组 & 干预措施
Waitlist Controlled Arm
The 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.
干预措施: Transitional Intervention for Hyperacusis in Autism (Other)
Watchlist Controlled Arm
Group 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."
干预措施: Transitional Intervention for Hyperacusis in Autism (Other)
结局指标
主要结局
Aided Modified Continuous Contour Test
时间窗: Baseline through study completion, an average of 1 year.
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.
次要结局
- Hyperacusis Questionnaire(Baseline through study completion, an average of 1 year.)
- Questionnaire on Hypersensitivity to Sound (GÜF)(Baseline through study completion, an average of 1 year.)
- Tampa Scale of Hyperacusis(Baseline through study completion, an average of 1 year.)
- Tinnitus Questionnaire(Baseline through study completion, an average of 1 year.)
- Noise Avoidance Questionnaire(Baseline through study completion, an average of 1 year.)
- Weinstein Noise Sensitivity Scale (WNSS-21)(Baseline through study completion, an average of 1 year.)
- Duke-Vanderbilt Misophonia Screening Questionnaire (DVMSQ)(Baseline through study completion, an average of 1 year.)
- DSM-5 Phonophobia Severity Scale(Baseline through study completion, an average of 1 year.)
- PROMIS Global-10(Baseline through study completion, an average of 1 year.)
- Social Responsiveness Scale-2 (SRS-2)(Baseline through study completion, an average of 1 year.)
- Short Sensory Profile 2 (SSP-2)(Baseline through study completion, an average of 1 year.)
- End of Intervention Survey(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(Baseline through study completion, an average of 1 year.)