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

NCT05976789 | Recruiting FDA Device

• 1 other identifier: M49LL3GGY7B5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Sound therapy; Counseling

Outcome Measures

Primary Outcomes (1)

• Change in hyperacusis symptoms from baseline to counseling at 8 weeks and sound therapy at 12 weeks

  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.

  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).

Secondary Outcomes (4)

• Change in hyperacusis problems from baseline to counseling at 8 weeks and sound therapy at 12 weeks

  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).

• Change in ratings of natural sounds using a psychoacoustic test from baseline to counseling at 8 weeks and sound therapy at 12 weeks

  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).

• Change in disability resulting from hyperacusis assessed at baseline to counseling at 8 weeks and sound therapy at 12 weeks

  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).

• Change in quality of life from baseline to counseling at 8 weeks and sound therapy at 12 weeks

  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).

Other Outcomes (1)

• Tinnitus Primary Functions Questionnaire (TFPQ)

  At baseline only

Study Arms (2)

HAT-Online Counseling

EXPERIMENTAL

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.

Behavioral: Remote counseling using HAT-Online

Sound therapy

EXPERIMENTAL

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.

Device: Sound therapy using low-level background sound; Other: Sound therapy using successive approximations

Interventions

Sound therapy using low-level background sound 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

Remote counseling using HAT-Online BEHAVIORAL

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

HAT-Online Counseling

Sound therapy using successive approximations OTHER

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

Sound therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Augustana College: lead

Study Sites (1)

Augustana College

Rock Island, Illinois, 61201, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Hyperacusis

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann Perreau, PhD

  Augustana College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Perreau, PhD

CONTACT

309-794-8935; Annperreau@augustana.edu

Austin Williamson, PhD

CONTACT

309-794-7367; jaustinwilliamson@augustana.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated Measures with two treatment groups

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 4, 2023
• Study Start: December 18, 2023
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The investigators will share these data in 2026 once the Phase I clinical trial is complete. Data will be shared for up to 5 years after the study's completion.
• Access Criteria: The investigators will employ Augustana College's Digital Commons that provides free and easy access to scholarly work of the faculty and students at Augustana College.

Locations

US (1)