<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/NCT03802513</url>
  </required_header>
  <id_info>
    <org_study_id>C3181-P</org_study_id>
    <secondary_id>1I21RX003181-01</secondary_id>
    <nct_id>NCT03802513</nct_id>
  </id_info>
  <brief_title>Somatosensory Tinnitus Study</brief_title>
  <official_title>A New Therapeutic Approach for Somatosensory Tinnitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Somatosensory tinnitus is suspected when the tinnitus perception changes following head,&#xD;
      neck, or jaw maneuvers. The prevalence of this type of tinnitus in Veterans in unknown. The&#xD;
      Cleveland Clinic evaluates all tinnitus patients for this condition and when detected,&#xD;
      prescribes individualized physiotherapy. Cleveland Clinic's novel approach to tinnitus&#xD;
      assessment and management provides the framework for this proof of concept pilot study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1A involves adapting Cleveland Clinic's assessment and treatment approach for&#xD;
      somatosensory tinnitus to make it feasible for a VA population.&#xD;
&#xD;
      Phase 1B involves screening Veterans with tinnitus to evaluate and describe the prevalence of&#xD;
      somatosensory tinnitus (in Veterans with tinnitus).&#xD;
&#xD;
      Phase 2 involves Veterans with somatosensory tinnitus receiving 3 individualized physical&#xD;
      therapy sessions using the adapted approach developed during Phase 1A.&#xD;
&#xD;
      Phase 3 will evaluate the feasibility and tolerability of the adapted treatment approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tinnitus Functional Index</measure>
    <time_frame>Baseline and 1 month follow-up</time_frame>
    <description>The TFI is a 25-item questionnaire that measures the functional effects of tinnitus. Total possible score ranges from 0-to-100 (scores &gt;25 indicate tinnitus is a significant problem).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Tinnitus</condition>
  <arm_group>
    <arm_group_label>Individualized Physiotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy</intervention_name>
    <description>Individualized physiotherapy including exercises to be performed by the Veteran at home.</description>
    <arm_group_label>Individualized Physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veteran&#xD;
&#xD;
          -  chronic tinnitus&#xD;
&#xD;
          -  positive screen for somatosensory tinnitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-Veteran&#xD;
&#xD;
          -  participation in new (&lt; 1 month) tinnitus management or treatment&#xD;
&#xD;
          -  current participation in tinnitus research involving an intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Theodoroff, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Portland Health Care System, Portland, OR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Portland Health Care System, Portland, OR</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>May 2022</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <results_first_submitted>February 23, 2022</results_first_submitted>
  <results_first_submitted_qc>May 16, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 17, 2022</results_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tinnitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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>December 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03802513/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03802513/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Individualized Physiotherapy</title>
          <description>This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.&#xD;
Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Individualized Physiotherapy</title>
          <description>This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.&#xD;
Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Tinnitus Functional Index</title>
        <description>The TFI is a 25-item questionnaire that measures the functional effects of tinnitus. Total possible score ranges from 0-to-100 (scores &gt;25 indicate tinnitus is a significant problem).</description>
        <time_frame>Baseline and 1 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Physiotherapy</title>
            <description>This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.&#xD;
Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home.</description>
          </group>
        </group_list>
        <measure>
          <title>Tinnitus Functional Index</title>
          <description>The TFI is a 25-item questionnaire that measures the functional effects of tinnitus. Total possible score ranges from 0-to-100 (scores &gt;25 indicate tinnitus is a significant problem).</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.7" spread="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.6" spread="26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The time frame for each participant's involvement in the study, and hence being monitored for adverse events, ranged from approximately 1 to 3 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Individualized Physiotherapy</title>
          <description>This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.&#xD;
Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home.</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="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </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="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>In-person research-related activities were limited due to COVID-19.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Principal Investigator</name_or_title>
      <organization>VA RR&amp;D National Center for Rehabilitative Auditory Research</organization>
      <phone>503-220-8262</phone>
      <email>sarah.theodoroff@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/NCT03802513
org study id: C3181-P
secondary id: 1I21RX003181-01
nct id: NCT03802513
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Somatosensory tinnitus is suspected when the tinnitus perception changes following head,
      neck, or jaw maneuvers. The prevalence of this type of tinnitus in Veterans in unknown. The
      Cleveland Clinic evaluates all tinnitus patients for this condition and when detected,
      prescribes individualized physiotherapy. Cleveland Clinic's novel approach to tinnitus
      assessment and management provides the framework for this proof of concept pilot study.
Phase 1A involves adapting Cleveland Clinic's assessment and treatment approach for
      somatosensory tinnitus to make it feasible for a VA population.

      Phase 1B involves screening Veterans with tinnitus to evaluate and describe the prevalence of
      somatosensory tinnitus (in Veterans with tinnitus).

      Phase 2 involves Veterans with somatosensory tinnitus receiving 3 individualized physical
      therapy sessions using the adapted approach developed during Phase 1A.

      Phase 3 will evaluate the feasibility and tolerability of the adapted treatment approach.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tinnitus Functional Index
time frame: Baseline and 1 month follow-up
description: The TFI is a 25-item questionnaire that measures the functional effects of tinnitus. Total possible score ranges from 0-to-100 (scores >25 indicate tinnitus is a significant problem).
arm group label: Individualized Physiotherapy
arm group type: Other
description: This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.
intervention type: Other
intervention name: Physical Therapy
description: Individualized physiotherapy including exercises to be performed by the Veteran at home.
arm group label: Individualized Physiotherapy
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Theodoroff, PhD
role: Principal Investigator
affiliation: VA Portland Health Care System, Portland, OR
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tinnitus
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: In-person research-related activities were limited due to COVID-19.
point of contact: 