Recruiting

Counseling & Sound Therapy

Sponsor:

Augustana College

Code:

NCT05976789

Conditions

Hyperacusis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sound therapy using low-level background sound

Remote counseling using HAT-Online

Sound therapy using successive approximations

Study Details

Brief summary:

There is no universal approach used to treat hyperacusis, a condition defined as having reactions to sound as too loud, annoying, fearful, or painful. A collaborative report published by prominent researchers recommended counseling and sound therapy for managing hyperacusis, but emphasized the need for rigorously designed clinical trials to assess the effectiveness of these treatments. The investigators developed a face-to-face counseling approach, Hyperacusis Activities Treatment (HAT), and have demonstrated its effectiveness for in-person therapy. In this study, the investigators will conduct a controlled trial to evaluate the effectiveness of the two components of HAT in managing hyperacusis: Aim 1, remotely delivered counseling, and Aim 2, sound therapy. In Aim 1, participants will complete four weeks of remote counseling using instructional videos, homework activities, discussion forums, and hands-on exercises. To ensure rigor in the approach, all participants will complete 4 weeks of weekly monitoring (control) before beginning counseling (treatment) for an additional 4 weeks. In aim 2, participants will be randomized into one of two sound therapy groups: (1) Group 1: Listen to their individually chosen bothersome sounds using successive approximations or a gradual increase in sound level; and (2) Group 2: Listen to continuous, low-level background noise. In both groups, devices will be fit remotely and used for 1-2 hours per day for four weeks. Completion of this R15 Academic Research Enhancement Award project at Augustana College will lead to a shift in hyperacusis management by providing early clinical evidence for the effectiveness of the components that make up the HAT protocol: counseling and sound therapy.

Conditions

Hyperacusis

Study ID

NCT05976789

Start date

Dec 18, 2023

Status verified date

Apr, 2024

Completion date

May, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe tinnitus
  • Hearing loss that is severe or profound
  • Recent history of hyperacusis counseling or treatment in last two months

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HAT-Online Counseling

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.

experimental: Sound therapy

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.

Interventions

Sound therapy using low-level background sound

This study will use an FDA-regulated device, a tinnitus masker, as one of the sound therapy options in Aim 2.

The tinnitus masker will provide low-level background sound for hyperacusis relief.

Remote counseling using HAT-Online

This study will implement Hyperacusis Activities Treatment-Online, a four-week remote counseling program in Aim 1.

Sound therapy using successive approximations

This study will use the approach of successive approximations with the participants' bothersome sounds in Aim 2.

Primary outcome measure

  • Change in hyperacusis symptoms from baseline to counseling at 8 weeks and sound therapy at 12 weeks [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Locations

Augustana College

Recruiting

Rock Island, Illinois, United States, 61201

Contacts

More Information

Sponsor

Augustana College

Last update posted

Apr 17, 2024

Last verified

Apr, 2024

Keywords

  • Sound therapy
  • Counseling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augustana College on 2024-04-17.