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RECRUITING
NCT05976789
NA

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

Sponsor: Augustana College

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-12-18

Completion Date

2026-05

Last Updated

2024-04-17

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

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.

BEHAVIORAL

Remote counseling using HAT-Online

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

OTHER

Sound therapy using successive approximations

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

Locations (1)

Augustana College

Rock Island, Illinois, United States