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

April 16, 2024 updated by: Augustana College
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Remote counseling using HAT-Online
This study will implement Hyperacusis Activities Treatment-Online, a four-week remote counseling program in Aim 1.
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.
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.

Other: Sound therapy using successive approximations
This study will use the approach of successive approximations with the participants' bothersome sounds in Aim 2.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in hyperacusis problems 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).
The Hyperacusis Problems Questionnaire (HPQ) is an open-ended questionnaire that assesses the number of problems that patients experience because of hyperacusis. The related problems are rank ordered to determine the most problematic situations affecting a patient with hyperacusis.
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
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).
In this psychoacoustic test, the participant is presented with a set of natural sounds and rates the sounds from pleasant to unpleasant using a visual analog scale. Sounds are presented via headphones using a tablet at multiple sound levels (60 and 80 dB SPL, or sound pressure level in decibels).
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
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).
A 10-item questionnaire that measures a patient's reactions to their hyperacusis using numerical ratings and bothersome sounds. Responses are differentiated based on the subtypes of hyperacusis including loudness, annoyance, fear, and pain. Participants rate the sounds using a scale from 0 (not loud/annoying/fearful/painful) to 100 (unbearably loud/annoying/fearful/painful).
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
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).
The Meaning of Life Questionnaire includes 23 items that assess quality of life using a broad perspective with items that load on four factors: friendship and positive outlook, physical health, hearing and mental health, and satisfaction with life. Participants rate their agreement with each statement from 0-100 (0=completely disagree; 100=completely agree) and then a total score is calculated based on the average of all 23 items.
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tinnitus Primary Functions Questionnaire (TFPQ)
Time Frame: At baseline only
This 12-item questionnaire determines the impact of tinnitus on one's lifestyle in four areas: concentration, thoughts and emotions, communication, and sleep. Participants rate their agreement with each statement from 0-100 (0=strongly disagree; 100=strongly agree) and then a total score is calculated based on the average of all 12 items. This questionnaire will screen for the presence of severe tinnitus.
At baseline only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Augustana College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann Perreau, PhD, Augustana College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M49LL3GGY7B5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing of data generated by this AREA R15 project will be carried out in several different ways. The research team will make results available to both the community of researchers and clinicians involved in hyperacusis assessment and management via an open access, online digital repository. Data to be shared as as follows: Categorical and numerical ratings from two hyperacusis questionnaires and reactions to sounds; open-ended responses to one hyperacusis questionnaire; psychoacoustic test; audiogram and hearing history information; percent compliance rate for the counseling program and rate of completion of homework and quizzes; number of hours sound therapy is used, and changes to volume via device datalogging; and characteristics of the participants.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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