Remote Counseling and Sound Therapy for Hyperacusis

This study is testing a new, fully remote program for hyperacusis, a condition where sounds are perceived as too loud, annoying, fearful, or painful. The program has two parts: first, a four-week online counseling program called HAT-Online. After counseling, participants will try one of two sound therapies for four weeks: either listening to their own bothersome sounds or using an FDA-regulated tinnitus masker device that provides low-level background sound. The study aims to see how much hyperacusis symptoms improve after counseling (at 8 weeks) and after sound therapy (at 12 weeks). You can join if you are 18 or older, have hyperacusis as your main diagnosis, and have access to a smartphone or computer. You cannot join if you have severe tinnitus, severe hearing loss, or have had hyperacusis treatment in the last two months. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 60 participants. It will evaluate a remote counseling program and then compare two different sound therapy approaches.
What's involved
You will participate in a four-week remote counseling program, followed by four weeks of sound therapy. Your symptoms will be measured at baseline, 4 weeks, 8 weeks, and 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your hyperacusis symptoms will be measured up to 12 weeks after starting the study interventions.

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NCT05976789

A Feasibility Study of a Novel, Fully Remote Counseling and Sound Therapy Program for Hyperacusis

UNKNOWN
NAAges 18+InterventionalTreatment
Augustana College
~60 participants
Updated 2024-04-17 on ClinicalTrials.gov
What's tested:Sound therapy using low-level background soundRemote counseling using HAT-OnlineSound therapy using successive approximations

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in hyperacusis symptoms from baseline to counseling at 8 weeks and sound therapy at 12 weeks
Measured over 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).
Hyperacusis
1 sites across 1 states
Illinois1
  • Ann Perreau, PhD · PRINCIPAL_INVESTIGATOR · Augustana College

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Eligibility criteria

Inclusion

Have hyperacusis as primary diagnosis
Have access to a smartphone or computer

Exclusion

Severe tinnitus
Hearing loss that is severe or profound
Recent history of hyperacusis counseling or treatment in last two months
  • Change in hyperacusis symptoms from baseline to counseling at 8 weeks and sound therapy at 12 weeksMeasurements 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).

    The Inventory of Hyperacusis Symptoms (IHS) is a 25-item questionnaire assessing hyperacusis reactions and severity, and allows for differentiation between the subtypes of hyperacusis including loudness and pain. Through psychometric evaluation, the IHS is a reliable and sensitive tool for assessing hyperacusis symptoms for research and clinical applications. Participants respond to each item using a 4-point scale from 1 = not at all to 4 = very much so.