Remote Counseling + Sound Therapy for Hyperacusis

Overseen By Austin Williamson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Augustana College

Disqualifiers: Severe tinnitus, Severe hearing loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for people with hyperacusis, a condition where everyday sounds seem too loud or painful. Researchers are exploring remote counseling using HAT-Online and sound therapy to evaluate their effectiveness in managing symptoms. Participants will first undergo online counseling for four weeks, then join one of two sound therapy groups for another four weeks. The trial seeks individuals diagnosed with hyperacusis who have access to a smartphone or computer. As an unphased trial, it offers a unique opportunity to contribute to understanding and improving hyperacusis treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the remote counseling and sound therapy under study for hyperacusis are safe. Earlier studies developed remote counseling programs for hyperacusis, and participants generally received them well. These studies did not identify any major safety issues or negative effects from participation.

For sound therapy, which uses low-level background noise, a review recommended this method for managing hyperacusis and found no serious safety concerns. Another type of sound therapy involves gradually increasing sound levels, which helped people tolerate sounds better over time without major negative effects.

Overall, earlier research found both the remote counseling and sound therapy treatments safe, with no significant reports of harm. This suggests that people with hyperacusis generally tolerate these treatments well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments for hyperacusis because they offer innovative approaches through remote counseling and sound therapy. Unlike traditional therapies that might require in-person sessions, the remote counseling option provides flexibility and accessibility for patients by using HAT-Online. Additionally, the sound therapy uses novel approaches like low-level background noise and successive approximations to help patients gradually adapt to bothersome sounds, which is different from the conventional desensitization methods. These features could potentially make managing hyperacusis more convenient and effective for many people.

What evidence suggests that this trial's treatments could be effective for hyperacusis?

This trial will evaluate two approaches for managing hyperacusis: remote counseling and sound therapy. Research has shown that remote counseling through HAT-Online, which participants in this trial may receive, helps people with hyperacusis by providing education and strategies to cope with bothersome sounds. Early results suggest that this type of remote counseling effectively manages hyperacusis symptoms.

For sound therapy, participants will be randomized to receive one of two approaches. One approach uses low-level background noise, and studies indicate it helps people tolerate louder sounds by making the brain less sensitive to noise. This method involves gradually exposing the ears to sound, making everyday noises feel less overwhelming.

The other sound therapy method involves listening to recordings of annoying sounds at low volumes and slowly increasing the volume. Research has found that this can improve loudness tolerance by 9-13 decibels, making everyday sounds more manageable for those with hyperacusis. Overall, both sound therapies show promise in managing hyperacusis symptoms. ^{3 6 7 8 9}

Who Is on the Research Team?

Ann Perreau, PhD

Principal Investigator

Augustana College

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Remote counseling using HAT-Online
• Sound therapy using low-level background sound
• Sound therapy using successive approximations

Trial Overview 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.

How Is the Trial Designed?

Group I: Sound therapy Experimental Treatment 2 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 Counseling Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Augustana College

Lead Sponsor

Trials

1

Recruited

60+

Published Research Related to This Trial

Internet-based interventions for tinnitus, particularly those incorporating cognitive behavioral therapy, significantly reduce tinnitus distress and improve related outcomes like anxiety and quality of life, with a moderate effect size of 0.59 compared to inactive controls.

In contrast, Internet interventions for hearing loss showed no significant effects overall, although a moderate effect was noted when excluding a study with high bias, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Interventions for Adults With Hearing Loss, Tinnitus, and Vestibular Disorders: A Systematic Review and Meta-Analysis. Beukes, EW., Manchaiah, V., Allen, PM., et al.[2020]

A group educational session for hyperacusis patients can effectively address their needs by providing information about the condition, its relationship to hearing loss and tinnitus, and available treatment options.

Feedback from 11 adults who attended the session highlighted the importance of reassurance and support from audiologists, emphasizing that a group approach can help patients feel less isolated and more connected in their therapeutic journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a Group Educational Session for Hyperacusis Patients. Perreau, AE., Tyler, RS., Mancini, PC., et al.[2019]

In a study of 14 patients with severe hyperacusis, experimental electronic loudness suppression devices were found to improve comfort by allowing a wider dynamic range of sound without sacrificing audibility, compared to traditional earplugs or earmuffs.

Most participants reported benefits from using these devices in various listening situations, indicating their potential as an effective intervention for managing loudness discomfort in hyperacusis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperacusis: case studies and evaluation of electronic loudness suppression devices as a treatment approach. Sammeth, CA., Preves, DA., Brandy, WT.[2019]

Internet-based cognitive behavioral therapy (ICBT) for tinnitus was successfully translated into Spanish, showing a large effect size (d = 0.90) in reducing tinnitus severity among 32 participants, indicating its potential effectiveness for Spanish speakers.

While the intervention was feasible, with no withdrawals, engagement and compliance were not optimal, suggesting the need for improvements in these areas and further research through a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioural therapy for tinnitus in Spanish: a global feasibility trial. Beukes, EW., Munzo, MF., Andersson, G., et al.[2022]

In a study involving 34 patients with hyperacusis, treatment using open-field nature sounds for 30 minutes daily led to normal discomfort thresholds within a maximum of 9 weeks.

The results suggest that this method of acoustic treatment is effective in significantly reducing hyperacusis symptoms in a relatively short duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Open-field treatment of hyperacusis]. Moliner Peiro, F., López González, MA., Alfaro García, J., et al.[2009]

The case report highlights the effective management of severe misophonia in an adult female through tinnitus retraining therapy, which aims to help her habituate to bothersome environmental sounds.

The use of a hybrid telemedicine approach during the COVID-19 pandemic allowed for flexible access to care, combining in-person visits with remote consultations, which facilitated ongoing support and treatment adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and Management of Misophonia Using a Hybrid Telecare Approach: A Case Report. Zitelli, L.[2022]

The study demonstrated that a full treatment combining scripted counseling and sound therapy significantly improved the auditory dynamic range (DR) in 36 participants with sensorineural hearing loss, achieving an efficacy rate of 82% compared to lower rates for partial treatments.

Sound therapy alone was found to be much more effective than counseling, indicating that while both components are important, the sound therapy is crucial for optimizing treatment outcomes in individuals with reduced sound tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Formby, C., Hawley, ML., Sherlock, LP., et al.[2022]

Individuals with chronic apraxia of speech (AOS) showed positive treatment gains from Sound Production Treatment (SPT) delivered via telehealth, indicating that this method can be effective for speech therapy.

The results were comparable to traditional in-person SPT, with one participant maintaining treatment gains at 2 and 6 weeks post-treatment, suggesting that telehealth can be a viable alternative for delivering speech therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Telehealth on the Efficacy of Sound Production Treatment. Kallhoff, L., Mauszycki, S., Rose, B., et al.[2023]

The study successfully adapted an Internet-based cognitive behavioral therapy (ICBT) platform for tinnitus treatment to meet U.S. regulatory standards and user needs, ensuring safety and compliance.

Both healthcare professionals (11 participants) and patients with bothersome tinnitus (8 participants) reported high levels of acceptance and satisfaction with the modified ICBT intervention, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Features, Functionality, and Acceptability of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States. Manchaiah, V., Vlaescu, G., Varadaraj, S., et al.[2021]

This systematic review aims to evaluate the efficacy and effectiveness of Internet-based interventions for adults with hearing loss, tinnitus, and vestibular disorders, highlighting the growing importance of accessible healthcare solutions.

The review will follow rigorous methodologies, including the use of the Cochrane risk of bias tool to assess included studies, ensuring that the findings will be reliable and valuable for guiding future auditory intervention research and clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based interventions for adults with hearing loss, tinnitus and vestibular disorders: a protocol for a systematic review. Beukes, EW., Manchaiah, V., Baguley, DM., et al.[2023]

A structured counseling protocol combined with low-level broadband sound therapy can help expand the auditory dynamic range for individuals with hearing impairments, particularly those with reduced loudness tolerance.

This approach has shown positive outcomes, including improved loudness discomfort levels and better daily communication, leading to increased satisfaction and effectiveness of hearing aids for patients with sensorineural hearing losses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structured Counseling for Auditory Dynamic Range Expansion. Gold, SL., Formby, C.[2020]

Citations

1. pubs.asha.org pubs.asha.org/doi/10.1044/2025_AJA-24-00229

Rationale and Development of a Remote Counseling ... Our remote counseling program, HAT-Online, provides holistic education about hyperacusis, coping strategies to lessen reactions to everyday sounds and challenge ...

2. reporter.nih.gov reporter.nih.gov/search/FIHE_HkhxkCQvf0SgXRE7g/project-details/10651126

RePORT RePORTER - National Institutes of Health (NIH) | The aim of this proposed R15 project is to gather early clinical evidence for the effectiveness of HAT in relieving hyperacusis using a novel, remote delivery ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05976789/a-feasibility-study-of-a-novel-fully-remote-counseling-and-sound-therapy-program-for-hyperacusis

A Feasibility Study of a Novel, Fully Remote Counseling and ... In this research study, the investigators will develop and test a novel, remote counseling program to reduce reactions to hyperacusis (Aim 1), and compare ...

4. withpower.com withpower.com/trial/phase-hyperacusis-11-2023-f998e

Remote Counseling + Sound Therapy for Hyperacusis 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 ...

5. iro.uiowa.edu iro.uiowa.edu/esploro/outputs/journalArticle/Rationale-and-Development-of-a-Remote/9984798227002771

Rationale and Development of a Remote Counseling Program ... Our remote counseling program, HAT-Online, provides holistic education about hyperacusis, coping strategies to lessen reactions to everyday ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40043222/

Rationale and Development of a Remote Counseling Program ... Purpose: This clinical focus article describes the development of a novel, remotely delivered counseling program for patients with hyperacusis.

7. ctv.veeva.com ctv.veeva.com/study/a-feasibility-study-of-a-novel-fully-remote-counseling-and-sound-therapy-program-for-hyperacusis

A Feasibility Study of a Novel, Fully Remote Counseling and ... In this research study, the investigators will develop and test a novel, remote counseling program to reduce reactions to hyperacusis (Aim 1), ...

8. pubs.asha.org pubs.asha.org/doi/10.1044/2024_AJA-23-00210

New Hyperacusis Therapy Combines Psychoeducation ... The aim of this study was to investigate the short- and long-term effects of a new cognitive sound exposure therapy (CSET) in patients with hyperacusis.

9. augustana.edu augustana.edu/about-us/news/augustanas-dr-ann-perreau-awarded-nih-grant-hyperacusis-study

Augustana's Dr. Ann Perreau awarded NIH grant for ... Ann Perreau's study will provide remote counseling and sound therapy to 60 adult participants across the nation. News. Augustana's Dr. Ann ...