xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05976789</url>
    </required_header>
    <id_info>
      <org_study_id>M49LL3GGY7B5</org_study_id>
      <nct_id>NCT05976789</nct_id>
    </id_info>
    <brief_title>A Feasibility Study of a Novel, Fully Remote Counseling and Sound Therapy Program for Hyperacusis</brief_title>
    <official_title>A Feasibility Study of a Novel, Fully Remote Counseling and Sound Therapy Program for Hyperacusis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Augustana College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Augustana College</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        There is no universal approach used to treat hyperacusis, a condition defined as having&#xD;
        reactions to sound as too loud, annoying, fearful, or painful. A collaborative report&#xD;
        published by prominent researchers recommended counseling and sound therapy for managing&#xD;
        hyperacusis, but emphasized the need for rigorously designed clinical trials to assess the&#xD;
        effectiveness of these treatments. The investigators developed a face-to-face counseling&#xD;
        approach, Hyperacusis Activities Treatment (HAT), and have demonstrated its effectiveness for&#xD;
        in-person therapy. In this study, the investigators will conduct a controlled trial to&#xD;
        evaluate the effectiveness of the two components of HAT in managing hyperacusis: Aim 1,&#xD;
        remotely delivered counseling, and Aim 2, sound therapy. In Aim 1, participants will complete&#xD;
        four weeks of remote counseling using instructional videos, homework activities, discussion&#xD;
        forums, and hands-on exercises. To ensure rigor in the approach, all participants will&#xD;
        complete 4 weeks of weekly monitoring (control) before beginning counseling (treatment) for&#xD;
        an additional 4 weeks. In aim 2, participants will be randomized into one of two sound&#xD;
        therapy groups: (1) Group 1: Listen to their individually chosen bothersome sounds using&#xD;
        successive approximations or a gradual increase in sound level; and (2) Group 2: Listen to&#xD;
        continuous, low-level background noise. In both groups, devices will be fit remotely and used&#xD;
        for 1-2 hours per day for four weeks. Completion of this R15 Academic Research Enhancement&#xD;
        Award project at Augustana College will lead to a shift in hyperacusis management by&#xD;
        providing early clinical evidence for the effectiveness of the components that make up the&#xD;
        HAT protocol: counseling and sound therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this research study, the investigators will develop and test a novel, remote counseling&#xD;
        program to reduce reactions to hyperacusis (Aim 1), and compare effectiveness of two sound&#xD;
        therapy options fitted remotely for managing hyperacusis symptoms (Aim 2). In Aim 1, all&#xD;
        participants will complete 4 weeks of weekly monitoring (control) before beginning counseling&#xD;
        (treatment) using the approach of Hyperacusis Activities Treatment through a combination of&#xD;
        recorded videos, hands-on activities, discussion forums, and quizzes for an additional 4&#xD;
        weeks. The investigators will share materials including the videos, hands-on activities, and&#xD;
        quizzes, via a secure learning management system that will provide easy access to all&#xD;
        participants. The counseling materials from HAT will focus on education about the auditory&#xD;
        system, loudness perception and mechanisms for hyperacusis, and the rationale for sound&#xD;
        therapy. After remote counseling, participants from Aim 1 will receive one of two sound&#xD;
        therapy approaches for hyperacusis relief in Aim 2. The investigators will randomize the&#xD;
        participants into one of two groups: 1) Group 1: listen to their individually chosen&#xD;
        bothersome sounds that trigger hyperacusis and 2) Group 2: listen to low-level, continuous&#xD;
        background noise (i.e., white noise). In both groups, participants will be fit remotely with&#xD;
        the devices and use sound therapy for four weeks. For Group 1, the student researchers will&#xD;
        record the three to four most bothersome sounds for the individual participant, provide&#xD;
        recordings of waveforms, and send equipment to participants for their use. In Group 2,&#xD;
        participants will listen to continuous, low-level broadband noise using sound generators&#xD;
        programmed and dispensed by the PI and student researchers. For both groups, the&#xD;
        investigators will track use and volume settings during the four-week trial using the&#xD;
        devices' data logging features. To determine the effectiveness of the two major components of&#xD;
        HAT in Aims 1 and 2, the investigators will employ quantitative measurements of the Inventory&#xD;
        of Hyperacusis (IHS), the Hyperacusis Problems Questionnaire (HPQ), the psychoacoustic test&#xD;
        using natural sounds, the Hyperacusis Disability and Handicap Scale, and the Meaning of Life&#xD;
        Questionnaire. The investigators will administer these measurements before and after&#xD;
        treatment for Aim 1, and before and after treatment for Aim 2. The primary interest is to&#xD;
        determine if the treatments show promise in treating hyperacusis. The investigators will&#xD;
        analyze the data by comparing mean difference scores using paired t-test within the same&#xD;
        group and independent samples t-test between the two groups for each treatment in Aim 2. The&#xD;
        results from power analyses suggest a reasonable effect size of 0.75 with a sample size of 29&#xD;
        subjects per group for Aim 2. A sample size of 30 per group is deemed appropriate to detect&#xD;
        significant differences for all proposed analyses. The power analysis is based on Aim 2;&#xD;
        therefore, there is ample power in Aim 1 to detect pre- and post-treatment differences. The&#xD;
        goal of enrolling 30 participants per group for this feasibility study is reasonable for the&#xD;
        research team (i.e., enroll two participants per month during the academic year and four&#xD;
        participants per month during the summer months).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">May 2026</completion_date>
    <primary_completion_date type="Anticipated">February 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Repeated Measures with two treatment groups</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in hyperacusis symptoms from baseline to counseling at 8 weeks and sound therapy at 12 weeks</measure>
      <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).</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in hyperacusis problems from baseline to counseling at 8 weeks and sound therapy at 12 weeks</measure>
      <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).</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ratings of natural sounds using a psychoacoustic test from baseline to counseling at 8 weeks and sound therapy at 12 weeks</measure>
      <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).</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in disability resulting from hyperacusis assessed at baseline to counseling at 8 weeks and sound therapy at 12 weeks</measure>
      <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).</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life from baseline to counseling at 8 weeks and sound therapy at 12 weeks</measure>
      <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).</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Tinnitus Primary Functions Questionnaire (TFPQ)</measure>
      <time_frame>At baseline only</time_frame>
      <description>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.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Hyperacusis</condition>
    <arm_group>
      <arm_group_label>HAT-Online Counseling</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sound therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sound therapy using low-level background sound</intervention_name>
      <description>This study will use an FDA-regulated device, a tinnitus masker, as one of the sound therapy options in Aim 2.&#xD;
  The tinnitus masker will provide low-level background sound for hyperacusis relief.</description>
      <arm_group_label>Sound therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Remote counseling using HAT-Online</intervention_name>
      <description>This study will implement Hyperacusis Activities Treatment-Online, a four-week remote counseling program in Aim 1.</description>
      <arm_group_label>HAT-Online Counseling</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sound therapy using successive approximations</intervention_name>
      <description>This study will use the approach of successive approximations with the participants' bothersome sounds in Aim 2.</description>
      <arm_group_label>Sound therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have hyperacusis as primary diagnosis&#xD;
  &#xD;
            -  Have access to a smartphone or computer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe tinnitus&#xD;
  &#xD;
            -  Hearing loss that is severe or profound&#xD;
  &#xD;
            -  Recent history of hyperacusis counseling or treatment in last two months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ann Perreau, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Augustana College</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ann Perreau, PhD</last_name>
      <phone>309-794-8935</phone>
      <email>Annperreau@augustana.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Austin Williamson, PhD</last_name>
      <phone>309-794-7367</phone>
      <email>jaustinwilliamson@augustana.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Augustana College</name>
        <address>
          <city>Rock Island</city>
          <state>Illinois</state>
          <zip>61201</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ann Perreau, Ph.D.</last_name>
        <phone>309-794-8935</phone>
        <email>Annperreau@augustana.edu</email>
      </contact>
      <contact_backup>
        <last_name>Austin Williamson, Ph.D.</last_name>
        <email>jaustinwilliamson@augustana.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://sites.google.com/augustana.edu/hear-t-hearingtinnitus/home</url>
      <description>The Hearing+Tinnitus (HEAR+T) lab website will have details about our research study.</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sound therapy</keyword>
    <keyword>Counseling</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperacusis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_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_time_frame>
      <ipd_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_access_criteria>
      <ipd_url>https://digitalcommons.augustana.edu/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05976789
  org study id: M49LL3GGY7B5
  nct id: NCT05976789
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  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.
  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).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Repeated Measures with two treatment groups
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  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).
  description: 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.
  measure: 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).
  description: 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.
  measure: 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).
  description: 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).
  measure: 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).
  description: 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).
  measure: 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).
  description: 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.
  measure: Tinnitus Primary Functions Questionnaire (TFPQ)
  time frame: At baseline only
  description: 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.
  arm group label: HAT-Online Counseling
  arm group type: Experimental
  description: 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.
  arm group label: Sound therapy
  arm group type: Experimental
  description: 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.
  intervention type: Device
  intervention name: Sound therapy using low-level background sound
  description: 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.
  arm group label: Sound therapy
  intervention type: Behavioral
  intervention name: Remote counseling using HAT-Online
  description: This study will implement Hyperacusis Activities Treatment-Online, a four-week remote counseling program in Aim 1.
  arm group label: HAT-Online Counseling
  intervention type: Other
  intervention name: Sound therapy using successive approximations
  description: This study will use the approach of successive approximations with the participants' bothersome sounds in Aim 2.
  arm group label: Sound therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ann Perreau, PhD
  role: Principal Investigator
  affiliation: Augustana College
  last name: Ann Perreau, PhD
  phone: 309-794-8935
  email: Annperreau@augustana.edu
  last name: Austin Williamson, PhD
  phone: 309-794-7367
  email: jaustinwilliamson@augustana.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  url: https://sites.google.com/augustana.edu/hear-t-hearingtinnitus/home
  description: The Hearing+Tinnitus (HEAR+T) lab website will have details about our research study.
  responsible party type: Sponsor
  mesh term: Hyperacusis
  sharing ipd: Yes
  ipd 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 info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd 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 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 url: https://digitalcommons.augustana.edu/