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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Have hyperacusis as primary diagnosis

• Have access to a smartphone or computer

Locations
United States
Illinois
Augustana College
RECRUITING
Rock Island
Contact Information
Primary
Ann Perreau, PhD
Annperreau@augustana.edu
309-794-8935
Backup
Austin Williamson, PhD
jaustinwilliamson@augustana.edu
309-794-7367
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2026-05
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Augustana College

This content was sourced from clinicaltrials.gov