HyperacusisNCT05976789
A Feasibility Study of a Novel, Fully Remote Counseling and Sound Therapy Program for Hyperacusis
A study testing Sound therapy using low-level background sound, Remote counseling using HAT-Online and Sound therapy using successive approximations in people with Hyperacusis, run by Augustana College at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperacusis
- What is being tested?
- Sound therapy using low-level background sound, Remote counseling using HAT-Online and Sound therapy using successive approximations
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2023to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have hyperacusis as primary diagnosis
- Have access to a smartphone or computer
Who cannot join
- Severe tinnitus
- Hearing loss that is severe or profound
- Recent history of hyperacusis counseling or treatment in last two months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augustana College
Rock Island, Illinois, 61201
Ann Perreau, Ph.D., 309-794-8935, Annperreau@augustana.edu
Austin Williamson, Ph.D., jaustinwilliamson@augustana.edu
About this study
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.
Read the 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
- Being tested
- Sound therapy using low-level background sound, Remote counseling using HAT-Online, Sound therapy using successive approximations
- Keywords
- Sound therapy, Counseling
- Medical subject headings
- Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound therapy using low-level background soundDevice
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.
Remote counseling using HAT-OnlineBehavioural
This study will implement Hyperacusis Activities Treatment-Online, a four-week remote counseling program in Aim 1.
Sound therapy using successive approximationsOther
This study will use the approach of successive approximations with the participants' bothersome sounds in Aim 2.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sound therapy using low-level background sound; Other: Sound therapy using successive approximations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start18 Dec 2023
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperacusisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Repeated Measures with two treatment groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augustana College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Perreau, PhD, Principal investigator, Augustana College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976789
- Sponsor's protocol ID
- M49LL3GGY7B5
- Status last verified
- Apr 2024
- First submitted
- 12 Jul 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Novel, Fully Remote Counseling and Sound Therapy Program for Hyperacusis
- ClinicalTrials.gov ID
- NCT05976789
- Acronym / sponsor ID
- M49LL3GGY7B5
- Conditions
- Hyperacusis
- Keywords
- Sound therapy, Counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Augustana CollegeUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Repeated Measures with two treatment groups
| Arm | Type | Receives |
|---|---|---|
| HAT-Online Counseling | Experimental | Behavioral: Remote counseling using HAT-OnlineIn 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. |
| Sound therapy | Experimental | Device: Sound therapy using low-level background sound, Other: Sound therapy using successive approximationsIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have hyperacusis as primary diagnosis
- Have access to a smartphone or computer
Key exclusion criteria (3 listed)
- Severe tinnitus
- Hearing loss that is severe or profound
- Recent history of hyperacusis counseling or treatment in last two months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound therapy using low-level background soundThis 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. | Device | Sound therapy |
| Remote counseling using HAT-OnlineThis study will implement Hyperacusis Activities Treatment-Online, a four-week remote counseling program in Aim 1. | Behavioural | HAT-Online Counseling |
| Sound therapy using successive approximationsThis study will use the approach of successive approximations with the participants' bothersome sounds in Aim 2. | Other | Sound therapy |
Primary outcome
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.
4 secondary outcomes
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- The Hearing+Tinnitus (HEAR+T) lab website will have details about our research study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Perreau, PhD principal investigator
Augustana College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound therapy using low-level background sound, Remote counseling using HAT-Online and Sound therapy using successive approximations in people with Hyperacusis, run by Augustana College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann Perreau, PhD (309-794-8935, Annperreau@augustana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.