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

NCT ID: NCT05976789

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2026-05-31

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.

Detailed Description

In this research study, the investigators will develop and test a novel, remote counseling program to reduce reactions to hyperacusis (Aim 1), and compare effectiveness of two sound therapy options fitted remotely for managing hyperacusis symptoms (Aim 2). In Aim 1, all participants will complete 4 weeks of weekly monitoring (control) before beginning counseling (treatment) using the approach of Hyperacusis Activities Treatment through a combination of recorded videos, hands-on activities, discussion forums, and quizzes for an additional 4 weeks. The investigators will share materials including the videos, hands-on activities, and quizzes, via a secure learning management system that will provide easy access to all participants. The counseling materials from HAT will focus on education about the auditory system, loudness perception and mechanisms for hyperacusis, and the rationale for sound therapy. After remote counseling, participants from Aim 1 will receive one of two sound therapy approaches for hyperacusis relief in Aim 2. The investigators will randomize the participants into one of two groups: 1) Group 1: listen to their individually chosen bothersome sounds that trigger hyperacusis and 2) Group 2: listen to low-level, continuous background noise (i.e., white noise). In both groups, participants will be fit remotely with the devices and use sound therapy for four weeks. For Group 1, the student researchers will record the three to four most bothersome sounds for the individual participant, provide recordings of waveforms, and send equipment to participants for their use. In Group 2, participants will listen to continuous, low-level broadband noise using sound generators programmed and dispensed by the PI and student researchers. For both groups, the investigators will track use and volume settings during the four-week trial using the devices' data logging features. To determine the effectiveness of the two major components of HAT in Aims 1 and 2, the investigators will employ quantitative measurements of the Inventory of Hyperacusis (IHS), the Hyperacusis Problems Questionnaire (HPQ), the psychoacoustic test using natural sounds, the Hyperacusis Disability and Handicap Scale, and the Meaning of Life Questionnaire. The investigators will administer these measurements before and after treatment for Aim 1, and before and after treatment for Aim 2. The primary interest is to determine if the treatments show promise in treating hyperacusis. The investigators will analyze the data by comparing mean difference scores using paired t-test within the same group and independent samples t-test between the two groups for each treatment in Aim 2. The results from power analyses suggest a reasonable effect size of 0.75 with a sample size of 29 subjects per group for Aim 2. A sample size of 30 per group is deemed appropriate to detect significant differences for all proposed analyses. The power analysis is based on Aim 2; therefore, there is ample power in Aim 1 to detect pre- and post-treatment differences. The goal of enrolling 30 participants per group for this feasibility study is reasonable for the research team (i.e., enroll two participants per month during the academic year and four participants per month during the summer months).

Conditions

Hyperacusis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote counseling using HAT-Online

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Sound therapy using low-level background sound

Intervention Type: DEVICE

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.

Sound therapy using successive approximations

Intervention Type: OTHER

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

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.

Intervention Type: DEVICE

Remote counseling using HAT-Online

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

Intervention Type: BEHAVIORAL

Sound therapy using successive approximations

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Augustana College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Perreau, PhD

Role: PRINCIPAL_INVESTIGATOR

Augustana College

Locations

Augustana College

Rock Island, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ann Perreau, PhD

Role: CONTACT

Annperreau@augustana.edu

309-794-8935

Austin Williamson, PhD

Role: CONTACT

jaustinwilliamson@augustana.edu

309-794-7367

Facility Contacts

Ann Perreau, Ph.D.

Role: primary

Annperreau@augustana.edu

309-794-8935

Austin Williamson, Ph.D.

Role: backup

jaustinwilliamson@augustana.edu

Related Links

https://sites.google.com/augustana.edu/hear-t-hearingtinnitus/home

The Hearing+Tinnitus (HEAR+T) lab website will have details about our research study.

Other Identifiers

M49LL3GGY7B5

Identifier Type: -

Identifier Source: org_study_id