<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/NCT03764826</url>
  </required_header>
  <id_info>
    <org_study_id>2018-P2-182-01</org_study_id>
    <nct_id>NCT03764826</nct_id>
  </id_info>
  <brief_title>Study on the Effect of Sound Therapy on Chronic Primary Tinnitus</brief_title>
  <official_title>Study on the Effect of Sound Therapy on Chronic Primary Tinnitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Friendship Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to compare the effect of Cochleural Alternating Acoustic Beam Therapy(CAABT)&#xD;
      and tinnitus masking therapy(TMT) on chronic primary tinnitus.Half of participants will&#xD;
      receive CAABT, while the other half will receive TMT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients with tinnitus will be collected with medical history, ear examination ,auditory&#xD;
      function test and questionnaire survey.100 cases of chronic primary tinnitus will be selected&#xD;
      as the research object.This study will be developed in the form of a blind randomized&#xD;
      clinical trial.The study subjects will be divided into 2 groups by randomized method, with 50&#xD;
      cases in each group. Psychological acoustic test, Resting-state function magnetic resonance&#xD;
      imaging（RS-fMRI) will be conducted.For 6 months, the patients will be treated with Cochleural&#xD;
      Alternating Acoustic Beam Therapy（CAABT）and tinnitus masking therapy（TMT） respectively,&#xD;
      followed by questionnaire survey, psychological acoustics test and RS-fMRI. The THI,VAS&#xD;
      score, RS-fMRI ReHo value and low-frequency wave amplitude (ALFF) before and after the&#xD;
      treatment will be compared. For those cases with poor results, the exchanged treatment will&#xD;
      be performed for 6 months, followed by questionnaire survey, psychoacoustic test, RS-fMRI,&#xD;
      and comparison of THI, VAS score, ReHo value and ALFF before and after treatment.All cases&#xD;
      will be followed up for 1 year, and questionnaire survey will be conducted again.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 8, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 8, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tinnitus Handicap Inventory ( THI)</measure>
    <time_frame>baseline, 2 months, 4 months, 6 months</time_frame>
    <description>Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Tinnitus Handicap Inventory scale.&#xD;
Efficacy evaluation criteria: (1) cure: THI score was reduced to less than 16 points;(2) significant effect: THI score decreased by more than 17 points;(3) invalid: THI score value decreased &lt; 17 points or even increased.Efficiency is the sum of cure and effect.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale(VAS)</measure>
    <time_frame>baseline, 2 months, 4 months, 6 months</time_frame>
    <description>Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Visual Analogue Scale(VAS).&#xD;
The number 0 to 10 indicates the severity of symptoms, &quot;0&quot; means no symptoms, and &quot;10&quot; means the most severe</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Tinnitus</condition>
  <arm_group>
    <arm_group_label>CAABT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CAABT(Cochleural Alternating Acoustic Beam Therapy) is an innovative tinnitus intervention which based on neural science and cochlear plastic research and aimed to reprogram the central auditory system to neutralize the discordant responses of the dysfunctioning cochlea via acoustic beaming stimuli.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CAABT</intervention_name>
    <description>The sound generators with CAABT will be used 15 min each session, three times a day</description>
    <arm_group_label>CAABT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TMT</intervention_name>
    <description>The sound generators with TMT will be used 15 min each session, three times a day</description>
    <arm_group_label>TMT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages between 18-75 years&#xD;
&#xD;
          -  Tinnitus undergone for more than 6 months&#xD;
&#xD;
          -  Continuous attack, single tone dominated, annoying tinnitus&#xD;
&#xD;
          -  Able to cooperate with auditory function test and psychoacoustic test&#xD;
&#xD;
          -  The main tinnitus frequency is from 125Hz to 8000Hz&#xD;
&#xD;
          -  Willing to use the equipment daily during the test&#xD;
&#xD;
          -  Willing and able to follow up regularly&#xD;
&#xD;
          -  Ability to read and write Chinese, able to understand and complete questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary tinnitus&#xD;
&#xD;
          -  Pure tone audiometry shows conduction deafness or mixed deafness&#xD;
&#xD;
          -  Tinnitus main frequency threshold &gt;60dB&#xD;
&#xD;
          -  Receiving treatment for other tinnitus&#xD;
&#xD;
          -  MRI contraindications&#xD;
&#xD;
          -  Feeling uncomfortable with the treatment equipment or not being accepted&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu-Sheng Gong, MD</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shu-Sheng Gong, MD</last_name>
    <phone>13911068366</phone>
    <email>50228354@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Friendship Hospital,Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100031</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shu-Sheng Gong, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Zhen-Chang Wang, MD</last_name>
      <phone>010-63138217</phone>
      <email>cjr.wzhch@vip.163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus executive summary. Otolaryngol Head Neck Surg. 2014 Oct;151(4):533-41. doi: 10.1177/0194599814547475.</citation>
    <PMID>25274374</PMID>
  </results_reference>
  <results_reference>
    <citation>Liu C, Lv H, Jiang T, Xie J, He L, Wang G, Liu J, Wang Z, Gong S. The Cochleural Alternating Acoustic Beam Therapy (CAABT): A pre-clinical trial. Am J Otolaryngol. 2018 Jul-Aug;39(4):401-409. doi: 10.1016/j.amjoto.2018.04.002. Epub 2018 Apr 3.</citation>
    <PMID>29655489</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 8, 2018</last_update_submitted>
  <last_update_submitted_qc>December 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Shu-sheng Gong</investigator_full_name>
    <investigator_title>director of Department of Otorhinolaryngology Head and Neck Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be made available within 6 months of study completion</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data access requests will be reviewed by an external Independent Review Panel.</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by an external Independent Review Panel</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03764826
org study id: 2018-P2-182-01
nct id: NCT03764826
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is to compare the effect of Cochleural Alternating Acoustic Beam Therapy(CAABT)
      and tinnitus masking therapy(TMT) on chronic primary tinnitus.Half of participants will
      receive CAABT, while the other half will receive TMT.
The patients with tinnitus will be collected with medical history, ear examination ,auditory
      function test and questionnaire survey.100 cases of chronic primary tinnitus will be selected
      as the research object.This study will be developed in the form of a blind randomized
      clinical trial.The study subjects will be divided into 2 groups by randomized method, with 50
      cases in each group. Psychological acoustic test, Resting-state function magnetic resonance
      imaging（RS-fMRI) will be conducted.For 6 months, the patients will be treated with Cochleural
      Alternating Acoustic Beam Therapy（CAABT）and tinnitus masking therapy（TMT） respectively,
      followed by questionnaire survey, psychological acoustics test and RS-fMRI. The THI,VAS
      score, RS-fMRI ReHo value and low-frequency wave amplitude (ALFF) before and after the
      treatment will be compared. For those cases with poor results, the exchanged treatment will
      be performed for 6 months, followed by questionnaire survey, psychoacoustic test, RS-fMRI,
      and comparison of THI, VAS score, ReHo value and ALFF before and after treatment.All cases
      will be followed up for 1 year, and questionnaire survey will be conducted again.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Tinnitus Handicap Inventory ( THI)
time frame: baseline, 2 months, 4 months, 6 months
description: Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Tinnitus Handicap Inventory scale.
Efficacy evaluation criteria: (1) cure: THI score was reduced to less than 16 points;(2) significant effect: THI score decreased by more than 17 points;(3) invalid: THI score value decreased < 17 points or even increased.Efficiency is the sum of cure and effect.
measure: Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value
time frame: baseline, 6 months
description: Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value
measure: Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)
time frame: baseline, 6 months
description: Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF
measure: Visual Analogue Scale(VAS)
time frame: baseline, 2 months, 4 months, 6 months
description: Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Visual Analogue Scale(VAS).
The number 0 to 10 indicates the severity of symptoms, "0" means no symptoms, and "10" means the most severe
arm group label: CAABT
arm group type: Experimental
description: CAABT(Cochleural Alternating Acoustic Beam Therapy) is an innovative tinnitus intervention which based on neural science and cochlear plastic research and aimed to reprogram the central auditory system to neutralize the discordant responses of the dysfunctioning cochlea via acoustic beaming stimuli.
arm group label: TMT
arm group type: Active Comparator
description: TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus.
intervention type: Device
intervention name: CAABT
description: The sound generators with CAABT will be used 15 min each session, three times a day
arm group label: CAABT
intervention type: Device
intervention name: TMT
description: The sound generators with TMT will be used 15 min each session, three times a day
arm group label: TMT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Shu-Sheng Gong, MD
role: Study Director
affiliation: Beijing Friendship Hospital
last name: Shu-Sheng Gong, MD
phone: 13911068366
email: 50228354@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus executive summary. Otolaryngol Head Neck Surg. 2014 Oct;151(4):533-41. doi: 10.1177/0194599814547475.
PMID: 25274374
citation: Liu C, Lv H, Jiang T, Xie J, He L, Wang G, Liu J, Wang Z, Gong S. The Cochleural Alternating Acoustic Beam Therapy (CAABT): A pre-clinical trial. Am J Otolaryngol. 2018 Jul-Aug;39(4):401-409. doi: 10.1016/j.amjoto.2018.04.002. Epub 2018 Apr 3.
PMID: 29655489
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Shu-sheng Gong
investigator title: director of Department of Otorhinolaryngology Head and Neck Surgery
mesh term: Tinnitus
sharing ipd: Yes
ipd description: Data will be made available within 6 months of study completion
ipd info type: Study Protocol
ipd time frame: Data access requests will be reviewed by an external Independent Review Panel.
ipd access criteria: Data access requests will be reviewed by an external Independent Review Panel