What is the mechanism of action of this treatment?

The most common treatments for hyperacusis, particularly those similar to the Hyperacusis Activities Treatment (HAT), include counseling and sound therapy. Counseling helps patients manage the emotional and psychological impact of hyperacusis by developing coping strategies and reducing anxiety related to sound exposure. Sound therapy involves the gradual exposure to sounds at increasing levels, which aims to desensitize the auditory system and improve sound tolerance. These treatments are crucial for hyperacusis patients as they address both the psychological and physiological components of the condition, offering a more holistic approach to managing their symptoms.

What side effects are associated with this type of intervention?

The most common treatments for hyperacusis, such as counseling and sound therapy, generally have minimal side effects. Counseling, which includes instructional videos, homework activities, and discussion forums, may occasionally cause emotional discomfort as patients confront their reactions to sound. Sound therapy, which involves listening to bothersome sounds or low-level background noise, may initially cause temporary discomfort or increased sensitivity to sound as patients adjust to the therapy. Overall, these treatments are considered safe and well-tolerated.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of hyperacusis. The primary treatments being studied, such as counseling and sound therapy, are non-pharmacological approaches and do not involve FDA-approved medications. These methods focus on managing the condition through behavioral and auditory interventions rather than pharmaceutical treatments.

What other types of research exist?

Promising novel alternatives to Hyperacusis Activities Treatment (HAT) for hyperacusis patients in 2024 may include: 1) Pharmacological treatments targeting the underlying neural mechanisms of hyperacusis, 2) Neuromodulation techniques such as transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS), and 3) Advanced auditory training programs using virtual reality (VR) or augmented reality (AR) to create controlled sound environments for desensitization.

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Behavioural Intervention

Remote Counseling + Sound Therapy for Hyperacusis

N/A

Recruiting

Led By Ann Perreau, PhD

Research Sponsored by Augustana College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have hyperacusis as primary diagnosis

Be older than 18 years old

Must not have

Hearing loss that is severe or profound

Severe tinnitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline only

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from listening to bothersome sounds during sound therapy sessions. However, since the interventions are non-invasive and involve counseling and controlled sound exposure, significant side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My main health issue is extreme sensitivity to sounds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe or profound hearing loss.

Select...

I have severe ringing in my ears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measurements will be completed four times during the study: 1) baseline, 2) four weeks (before aim 1), 3) eight weeks (end aim 1, before aim 2), and 4) 12 weeks (end aim 2).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measurements will be completed four times during the study: 1) baseline, 2) four weeks (before aim 1), 3) eight weeks (end aim 1, before aim 2), and 4) 12 weeks (end aim 2).

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurements will be completed four times during the study: 1) baseline, 2) four weeks (before aim 1), 3) eight weeks (end aim 1, before aim 2), and 4) 12 weeks (end aim 2). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in hyperacusis symptoms from baseline to counseling at 8 weeks and sound therapy at 12 weeks

Secondary study objectives

Change in disability resulting from hyperacusis assessed at baseline to counseling at 8 weeks and sound therapy at 12 weeks

Change in hyperacusis problems from baseline to counseling at 8 weeks and sound therapy at 12 weeks

Change in quality of life from baseline to counseling at 8 weeks and sound therapy at 12 weeks

+1 more

Other study objectives

Tinnitus Primary Functions Questionnaire (TFPQ)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for hyperacusis, particularly those similar to the Hyperacusis Activities Treatment (HAT), include counseling and sound therapy. Counseling helps patients manage the emotional and psychological impact of hyperacusis by developing coping strategies and reducing anxiety related to sound exposure. Sound therapy involves the gradual exposure to sounds at increasing levels, which aims to desensitize the auditory system and improve sound tolerance. These treatments are crucial for hyperacusis patients as they address both the psychological and physiological components of the condition, offering a more holistic approach to managing their symptoms.

A Systematic Review and Meta-Analysis Exploring Effects of Third-Wave Psychological Therapies on Hearing-Related Distress, Depression, Anxiety, and Quality of Life in People With Audiological Problems.Clinical Interventions for Hyperacusis in Adults: A Scoping Review to Assess the Current Position and Determine Priorities for Research.The Effect of Physical Therapy Treatment in Patients with Subjective Tinnitus: A Systematic Review.