<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/NCT03022084</url>
  </required_header>
  <id_info>
    <org_study_id>PVARF-387005</org_study_id>
    <nct_id>NCT03022084</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus</brief_title>
  <official_title>Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA National Center for Rehabilitative Auditory Research</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Desyncra, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA National Center for Rehabilitative Auditory Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if a novel sound-based therapy in comparison to&#xD;
      standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects&#xD;
      for people with bothersome tinnitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled trial evaluating if a customized sound-therapy device&#xD;
      is just as effective or more so, than the standard of care (cognitive behavioral therapy,&#xD;
      CBT) for bothersome tinnitus. All eligible participants will be randomly assigned to one of&#xD;
      the two groups. Depending on group assignment, participants will attend approximately 7-12&#xD;
      visits over a 7-month period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tinnitus Questionnaire (TQ)</measure>
    <time_frame>24-weeks</time_frame>
    <description>52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Tinnitus</condition>
  <arm_group>
    <arm_group_label>Desyncra</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard of Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Desyncra</intervention_name>
    <description>This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.</description>
    <arm_group_label>Desyncra</arm_group_label>
    <other_name>Desyncra™ for Tinnitus Therapy System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy</intervention_name>
    <description>Standard of Care</description>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <other_name>CBT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Primary and persistent tinnitus (6 months or longer in duration)&#xD;
&#xD;
          -  Tonal tinnitus&#xD;
&#xD;
          -  Dominant tinnitus frequency measured between 0.2 and 10 kHz&#xD;
&#xD;
          -  Tinnitus Questionnaire score&#xD;
&#xD;
          -  No current participation in other tinnitus therapy program&#xD;
&#xD;
          -  Willing and able to listen to the acoustic prescription for 4-6 hours daily during the&#xD;
             trial&#xD;
&#xD;
          -  Able to pass the Tone Audibility Assessment with factor of 1.1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary/somatic tinnitus due to a suspected underlying disease&#xD;
&#xD;
          -  Atonal, pulsatile, intermittent, or occasional tinnitus&#xD;
&#xD;
          -  Any hearing threshold &gt;70 dB HL from .25-8kHz, unless subject passes the Tone&#xD;
             Audibility Assessment screening with a factor of 1.1&#xD;
&#xD;
          -  Any health or other problems that may prevent the person from completing the study&#xD;
             procedures as determined by investigator&#xD;
&#xD;
          -  Participant reports current suicidal ideation and/or homicidal ideation&#xD;
&#xD;
          -  Use of medication which may trigger tinnitus [e.g., quinine derivatives,&#xD;
             aminoglycoside antibiotics, daily high dose non-steroidal anti-inflammatory drugs&#xD;
             ≥1000 mg, salicylates (when not prescribed as a low dose for cardiac health), loop&#xD;
             diuretics and chemotherapy agents like cis-platin]&#xD;
&#xD;
          -  Conductive hearing loss&#xD;
&#xD;
          -  Visible congenital or traumatic deformity of the ear&#xD;
&#xD;
          -  History of active drainage from the ear within the past 90 days&#xD;
&#xD;
          -  History of sudden or rapidly progressive hearing loss within the past 90 days&#xD;
&#xD;
          -  Inability to read and respond appropriately to instructions that appear on the&#xD;
             computer screen, and/or to perform all of the procedures&#xD;
&#xD;
          -  Previous use of Desyncra for Tinnitus Therapy System&#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>James Henry (PI), PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA RR&amp;D NCRAR</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sarah Theodoroff (Co-PI), PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA RR&amp;D NCRAR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Portland Health Care System, National Center for Rehabilitative Auditory Research</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>June 25, 2020</results_first_submitted>
  <results_first_submitted_qc>June 25, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 13, 2020</results_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA National Center for Rehabilitative Auditory Research</investigator_affiliation>
    <investigator_full_name>Sarah Theodoroff</investigator_full_name>
    <investigator_title>Research Investigator</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>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03022084/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Desyncra</title>
          <description>This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.&#xD;
Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.</description>
        </group>
        <group group_id="P2">
          <title>Cognitive Behavioral Therapy</title>
          <description>Standard of Care&#xD;
Cognitive Behavioral Therapy: Standard of Care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Individuals with bothersome tinnitus</population>
      <group_list>
        <group group_id="B1">
          <title>Desyncra</title>
          <description>This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.&#xD;
Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.</description>
        </group>
        <group group_id="B2">
          <title>Cognitive Behavioral Therapy</title>
          <description>Standard of Care&#xD;
Cognitive Behavioral Therapy: Standard of Care</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Tinnitus Questionnaire (TQ)</title>
        <description>52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome</description>
        <time_frame>24-weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Desyncra</title>
            <description>This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.&#xD;
Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Behavioral Therapy</title>
            <description>Standard of Care&#xD;
Cognitive Behavioral Therapy: Standard of Care</description>
          </group>
        </group_list>
        <measure>
          <title>Tinnitus Questionnaire (TQ)</title>
          <description>52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.3" spread="16.5"/>
                    <measurement group_id="O2" value="35.1" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The probability that Desyncra is non-inferior to CBT, defined by the sponsor as the event that mean TQ score change from baseline in the Desyncra arm is no more than 3.5 points worse than the mean TQ change in the CBT arm.</non_inferiority_desc>
            <other_analysis_desc>Data collected to date were analyzed using a Bayesian approach.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years, 5 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Desyncra</title>
          <description>This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.&#xD;
Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.</description>
        </group>
        <group group_id="E2">
          <title>Cognitive Behavioral Therapy</title>
          <description>Standard of Care&#xD;
Cognitive Behavioral Therapy: Standard of Care</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. James Henry</name_or_title>
      <organization>VA RR&amp;D National Center for Rehabilitative Auditory Research</organization>
      <phone>503-220-8262</phone>
      <email>James.Henry@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03022084
org study id: PVARF-387005
nct id: NCT03022084
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if a novel sound-based therapy in comparison to
      standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects
      for people with bothersome tinnitus.
This study is a randomized controlled trial evaluating if a customized sound-therapy device
      is just as effective or more so, than the standard of care (cognitive behavioral therapy,
      CBT) for bothersome tinnitus. All eligible participants will be randomly assigned to one of
      the two groups. Depending on group assignment, participants will attend approximately 7-12
      visits over a 7-month period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tinnitus Questionnaire (TQ)
time frame: 24-weeks
description: 52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome
arm group label: Desyncra
arm group type: Experimental
description: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
arm group label: Cognitive Behavioral Therapy
arm group type: Other
description: Standard of Care
intervention type: Device
intervention name: Desyncra
description: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
arm group label: Desyncra
other name: Desyncra™ for Tinnitus Therapy System
intervention type: Other
intervention name: Cognitive Behavioral Therapy
description: Standard of Care
arm group label: Cognitive Behavioral Therapy
other name: CBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James Henry (PI), PhD
role: Principal Investigator
affiliation: VA RR&D NCRAR
last name: Sarah Theodoroff (Co-PI), PhD
role: Principal Investigator
affiliation: VA RR&D NCRAR
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA National Center for Rehabilitative Auditory Research
investigator full name: Sarah Theodoroff
investigator title: Research Investigator
mesh term: Tinnitus
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 