Remote Counseling + Sound Therapy for Hyperacusis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Augustana College
Disqualifiers: Severe tinnitus, Severe hearing loss, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a new treatment for people who find normal sounds too loud or painful. The treatment includes online therapy sessions and listening to specific sounds to help reduce sensitivity. The goal is to see if these methods can effectively manage hyperacusis.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for guidance.
What data supports the effectiveness of the treatment Remote Counseling + Sound Therapy for Hyperacusis?
Research on internet-based interventions for tinnitus, which is a condition related to hyperacusis, shows that these interventions can significantly reduce distress and improve quality of life. Additionally, group educational sessions for hyperacusis patients have been found to provide support and guidance, suggesting that remote counseling could be beneficial.
12345Is remote counseling and sound therapy for hyperacusis safe for humans?
The available research on internet-based interventions, including cognitive behavioral therapy for tinnitus, suggests that these types of treatments are generally safe and well-accepted by users. However, specific safety data for remote counseling and sound therapy for hyperacusis is not directly addressed in the studies reviewed.
23467How does the Remote Counseling + Sound Therapy treatment for hyperacusis differ from other treatments?
This treatment is unique because it combines remote counseling with sound therapy using low-level background noise, aiming to gradually increase sound tolerance. Unlike other treatments that may rely on passive devices like earplugs, this approach actively works to expand the auditory dynamic range, helping patients become more comfortable with everyday sounds.
5891011Eligibility Criteria
This trial is for individuals with hyperacusis, a condition where sounds are perceived as too loud or painful. Participants must have access to a smartphone or computer and should not have severe tinnitus, profound hearing loss, or recent hyperacusis treatment.Inclusion Criteria
Have access to a smartphone or computer
My main health issue is extreme sensitivity to sounds.
Exclusion Criteria
I have received treatment or counseling for hyperacusis in the last two months.
I have severe or profound hearing loss.
I have severe ringing in my ears.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Control
Participants undergo a 4-week period of weekly monitoring before starting treatment
4 weeks
Remote monitoring
Counseling
Participants receive remote counseling using instructional videos, homework activities, discussion forums, and hands-on exercises
4 weeks
Remote sessions
Sound Therapy
Participants are randomized into two groups to receive sound therapy: listening to bothersome sounds or low-level background noise
4 weeks
Remote device fitting and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests two treatments for hyperacusis: remote counseling via videos and activities (HAT-Online), and sound therapy either through gradual exposure to bothersome sounds or continuous low-level background noise. The effectiveness of these methods will be compared over four weeks.
2Treatment groups
Experimental Treatment
Group I: Sound therapyExperimental Treatment2 Interventions
In Aim 2, the investigators will randomize the 60 participants to receive intervention using one of the two sound therapy approaches. Group 1: Listening to bothersome sounds or Group 2: Listening to low-level background noise.
Group II: HAT-Online CounselingExperimental Treatment1 Intervention
In Aim 1, the investigators will provide remote counseling for four weeks to 60 participants and compare results to baseline. All participants will be in a wait list control for four weeks before the counseling begins.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Augustana CollegeRock Island, IL
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Who Is Running the Clinical Trial?
Augustana CollegeLead Sponsor
References
The Impact of Telehealth on the Efficacy of Sound Production Treatment. [2023]This investigation was designed to systematically examine the acquisition, maintenance, and response generalization effects of Sound Production Treatment (SPT) delivered via telehealth in comparison to existing in-person outcomes for SPT.
Features, Functionality, and Acceptability of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States. [2021]Objective Although tinnitus is one of the most commonly reported symptoms in the general population, patients with bothersome tinnitus are challenged by issues related to accessibility of care and intervention options that lack strong evidence to support their use. Therefore, creative ways of delivering evidence-based interventions are necessary. Internet-based cognitive behavioral therapy (ICBT) demonstrates potential as a means of delivering this support but is not currently available in the United States. This article discusses the adaptation of an ICBT intervention, originally used in Sweden, Germany, and the United Kingdom, for delivery in the United States. The aim of this study was to (a) modify the web platform's features to suit a U.S. population, (b) adapt its functionality to comply with regulatory aspects, and (c) evaluate the credibility and acceptability of the ICBT intervention from the perspective of health care professionals and patients with bothersome tinnitus. Materials/Method Initially, the iTerapi ePlatform developed in Sweden was adopted for use in the United States. Functional adaptations followed to ensure that the platform's functional and security features complied with both institutional and governmental regulations and that it was suitable for a U.S. population. Following these adaptations, credibility and acceptance of the materials were evaluated by both health care professionals (n = 11) and patients with bothersome tinnitus (n = 8). Results Software safety and compliance regulatory assessments were met. Health care professionals and patients reported favorable acceptance and satisfaction ratings regarding the content, suitability, presentation, usability, and exercises provided in the ICBT platform. Modifications to the features and functionality of the platform were made according to user feedback. Conclusions Ensuring that the ePlatform employed the appropriate features and functionalities for the intended population was essential to developing the Internet-based interventions. The favorable user evaluations indicated that the intervention materials were appropriate for the tinnitus population in the United States.
Internet-Based Interventions for Adults With Hearing Loss, Tinnitus, and Vestibular Disorders: A Systematic Review and Meta-Analysis. [2020]Internet-based interventions have been developed to improve access to audiovestibular health care. This review aimed to identify outcomes of Internet interventions for adults with hearing loss, tinnitus, and vestibular disorders. Electronic databases and manual searches were performed to identify studies meeting eligibility for inclusion. Fifteen studies (1,811 participants) met the inclusion criteria, with nine studies targeting tinnitus distress, five considering hearing loss, and one for vestibular difficulties. Only the tinnitus and hearing loss Internet intervention studies were eligible for data synthesis. Internet-based interventions for hearing loss were diverse. Overall, they showed no significant effects, although a statistically significant moderate effect (d = 0.59) was found after removing the study with the highest risk of bias (as a result of high attrition). Most Internet-based interventions for tinnitus provided cognitive behavioural therapy. They yielded statistically significant mean effect sizes for reducing tinnitus distress compared with both inactive (d = 0.59) and active controls (d = 0.32). Significant effects were also present for the secondary outcomes of anxiety, depression, insomnia, and quality of life (combined effect d = 0.28). Only Internet-based interventions for tinnitus evaluated the 1-year postintervention effects indicated that results were maintained long term (d = 0.45). Scientific study quality was appraised using the Grading of Recommendations Assessment, Development and Evaluation approach and found to vary from very low to moderate. This review indicates the potential of Internet interventions for tinnitus to provide evidence-based accessible care. There is a need for additional high-quality evidence before conclusive results can be established regarding the effects of audiovestibular Internet interventions.
Establishing a Group Educational Session for Hyperacusis Patients. [2019]Purpose Audiologists should be treating hyperacusis patients. However, it can be difficult to know where to begin because treatment protocols and evidence-based treatment studies are lacking. A good place to start in any tinnitus and hyperacusis clinic is to incorporate a group educational session. Method Here, we outline our approach to establishing a hyperacusis group educational session that includes specific aspects of getting to know each patient to best meet their needs, understanding the problems associated with hyperacusis, explaining the auditory system and the relationship of hyperacusis to hearing loss and tinnitus, describing the influence of hyperacusis on daily life, and introducing treatment options. Subjective responses from 11 adults with hyperacusis, who participated in a recent clinical group education session, were discussed to illustrate examples from actual patients. Conclusions Due to the devastating nature of hyperacusis, patients need to be reassured that they are not alone and that they can rely on audiologists to provide support and guidance. A group approach can facilitate the therapeutic process by connecting patients with others who are also affected by hyperacusis, and by educating patients and significant others on hyperacusis and its treatment options. Supplemental Material https://doi.org/10.23641/asha.8121197.
[Open-field treatment of hyperacusis]. [2009]Prospective study of the effectiveness of treatment in patients with hyperacusis by means of an open-field technique of acoustic treatment with nature sounds.
Internet-based cognitive behavioural therapy for tinnitus in Spanish: a global feasibility trial. [2022]Internet-based cognitive behavioural therapy (ICBT) for tinnitus is an evidence-based intervention, but only available in a few languages. To increase accessibility, ICBT was translated into Spanish. This study's objective was to determine the feasibility of ICBT for Spanish speakers.
Internet-based interventions for adults with hearing loss, tinnitus and vestibular disorders: a protocol for a systematic review. [2023]Internet-based interventions are emerging as an alternative way of delivering accessible healthcare for various conditions including hearing and balance disorders. A comprehensive review regarding the evidence-base of Internet-based interventions for auditory-related conditions is required to determine the existing evidence of their efficacy and effectiveness. The objective of the current protocol is to provide the methodology for a systematic review regarding the effects of Internet-based interventions for adults with hearing loss, tinnitus and vestibular disorders.
Structured Counseling for Auditory Dynamic Range Expansion. [2020]A structured counseling protocol is described that, when combined with low-level broadband sound therapy from bilateral sound generators, offers audiologists a new tool for facilitating the expansion of the auditory dynamic range (DR) for loudness. The protocol and its content are specifically designed to address and treat problems that impact hearing-impaired persons who, due to their reduced DRs, may be limited in the use and benefit of amplified sound from hearing aids. The reduced DRs may result from elevated audiometric thresholds and/or reduced sound tolerance as documented by lower-than-normal loudness discomfort levels (LDLs). Accordingly, the counseling protocol is appropriate for challenging and difficult-to-fit persons with sensorineural hearing losses who experience loudness recruitment or hyperacusis. Positive treatment outcomes for individuals with the former and latter conditions are highlighted in this issue by incremental shifts (improvements) in LDL and/or categorical loudness judgments, associated reduced complaints of sound intolerance, and functional improvements in daily communication, speech understanding, and quality of life leading to improved hearing aid benefit, satisfaction, and aided sound quality, posttreatment.
Hyperacusis: case studies and evaluation of electronic loudness suppression devices as a treatment approach. [2019]Hyperacusis, as defined here, is a relatively rare condition in which the patient, with or without hearing loss, experiences severe loudness discomfort to everyday environmental sound levels. The case studies of 14 patients with severe hyperacusis are described; all wore passive attenuators (earplugs and/or earmuffs) in an attempt to alleviate their discomfort, frequently producing communication difficulties. These subjects were fitted binaurally with experimental electronic loudness suppression devices housed in in-the-ear casings. The devices supplied low-level amplification followed by an extreme form of amplitude compression for moderate or high-level inputs in an attempt to reduce loudness discomfort without reducing audibility. Many of the subjects were found to function with a wider dynamic range with the active devices compared with passive attenuators or the unoccluded ear, and most reported that they benefited from the devices in at least some listening situations.
Evaluation and Management of Misophonia Using a Hybrid Telecare Approach: A Case Report. [2022]Decreased sound tolerance (DST) is a negative reaction to environmental sounds and is estimated to affect 3.5% of the population. This case report presents the evaluation and management of an adult female with severe, longstanding misophonia. Her evaluation included comprehensive audiometric testing (including uncomfortable loudness levels) and a detailed assessment of the impact of DST on her life. She enrolled in tinnitus retraining therapy and began receiving treatment aiming to facilitate habituation of bothersome environmental sounds. This case was complicated by the advent of the coronavirus disease 2019 (COVID-19) pandemic and a telemedicine hybrid approach was employed to increase access to audiologic care. Using this structure, some appointments occurred in person in the clinic and others occurred via a telemedicine video visit format. Telemedicine video visits facilitated in-depth discussions, afforded the opportunity to answer questions, and provided the option of cloud-based remote programming of on-ear devices. Future care will continue to employ a hybrid approach.
A Sound Therapy-Based Intervention to Expand the Auditory Dynamic Range for Loudness among Persons with Sensorineural Hearing Losses: A Randomized Placebo-Controlled Clinical Trial. [2022]The primary aim of this research was to evaluate the validity, efficacy, and generalization of principles underlying a sound therapy-based treatment for promoting expansion of the auditory dynamic range (DR) for loudness. The basic sound therapy principles, originally devised for treatment of hyperacusis among patients with tinnitus, were evaluated in this study in a target sample of unsuccessfully fit and/or problematic prospective hearing aid users with diminished DRs (owing to their elevated audiometric thresholds and reduced sound tolerance). Secondary aims included: (1) delineation of the treatment contributions from the counseling and sound therapy components to the full-treatment protocol and, in turn, the isolated treatment effects from each of these individual components to intervention success; and (2) characterization of the respective dynamics for full, partial, and control treatments. Thirty-six participants with bilateral sensorineural hearing losses and reduced DRs, which affected their actual or perceived ability to use hearing aids, were enrolled in and completed a placebo-controlled (for sound therapy) randomized clinical trial. The 2 × 2 factorial trial design was implemented with or without various assignments of counseling and sound therapy. Specifically, participants were assigned randomly to one of four treatment groups (nine participants per group), including: (1) group 1-full treatment achieved with scripted counseling plus sound therapy implemented with binaural sound generators; (2) group 2-partial treatment achieved with counseling and placebo sound generators (PSGs); (3) group 3-partial treatment achieved with binaural sound generators alone; and (4) group 4-a neutral control treatment implemented with the PSGs alone. Repeated measurements of categorical loudness judgments served as the primary outcome measure. The full-treatment categorical-loudness judgments for group 1, measured at treatment termination, were significantly greater than the corresponding pretreatment judgments measured at baseline at 500, 2,000, and 4,000 Hz. Moreover, increases in their "uncomfortably loud" judgments (∼12 dB over the range from 500 to 4,000 Hz) were superior to those measured for either of the partial-treatment groups 2 and 3 or for control group 4. Efficacy, assessed by treatment-related criterion increases ≥ 10 dB for judgments of uncomfortable loudness, was superior for full treatment (82% efficacy) compared with that for either of the partial treatments (25% and 40% for counseling combined with the placebo sound therapy and sound therapy alone, respectively) or for the control treatment (50%). The majority of the group 1 participants achieved their criterion improvements within 3 months of beginning treatment. The treatment effect from sound therapy was much greater than that for counseling, which was statistically indistinguishable in most of our analyses from the control treatment. The basic principles underlying the full-treatment protocol are valid and have general applicability for expanding the DR among individuals with sensorineural hearing losses, who may often report aided loudness problems. The positive full-treatment effects were superior to those achieved for either counseling or sound therapy in virtual or actual isolation, respectively; however, the delivery of both components in the full-treatment approach was essential for an optimum treatment outcome.