<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/NCT02974543</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00088432</org_study_id>
    <nct_id>NCT02974543</nct_id>
  </id_info>
  <brief_title>Auditory-somatosensory Stimulation to Alleviate Tinnitus</brief_title>
  <official_title>Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wallace H Coulter Center for Translational Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to develop and test a subject operated device to lessen tinnitus&#xD;
      (ringing in the ear), based on subject-feedback for stimulus presentation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consented 35 adult subjects. 21 subjects qualified and were randomized into the&#xD;
      study. This project will develop and test a device with the ultimate goal of providing a&#xD;
      patient operated device to alleviate phantom sound perception, or tinnitus, based on&#xD;
      patient-feedback for stimulus presentation.&#xD;
&#xD;
      The device, an electrical-acoustical stimulus timing, is based on physiological findings of&#xD;
      stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant,&#xD;
      contribute to tinnitus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline</measure>
    <time_frame>Four weeks on treatment (or sham)</time_frame>
    <description>Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Tinnitus Loudness as Assessed by TinnTester</measure>
    <time_frame>4 weeks on treatment (or sham)</time_frame>
    <description>Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Tinnitus</condition>
  <arm_group>
    <arm_group_label>Sham 1st (Auditory only) then Active (Bimodal)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.&#xD;
During active treatment, the device will deliver electric somatosensory and auditory stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active (Bimodal) then Sham (Auditory only)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>During active treatment, the device will deliver electric somatosensory and auditory stimulation.&#xD;
To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Treatment: unimodal auditory stimulation</intervention_name>
    <description>All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.</description>
    <arm_group_label>Active (Bimodal) then Sham (Auditory only)</arm_group_label>
    <arm_group_label>Sham 1st (Auditory only) then Active (Bimodal)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Treatment: Bimodal auditory-somatosensory stimulation</intervention_name>
    <description>Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.&#xD;
The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.</description>
    <arm_group_label>Active (Bimodal) then Sham (Auditory only)</arm_group_label>
    <arm_group_label>Sham 1st (Auditory only) then Active (Bimodal)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Constant, subjective, preferably unilateral tinnitus without any active external or&#xD;
             middle ear pathology.&#xD;
&#xD;
          2. Hearing thresholds better than 50dB HL at peak tinnitus frequencies.&#xD;
&#xD;
          3. Able to modulate their tinnitus with a somatic maneuver&#xD;
&#xD;
          4. BothersomeTinnitus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No participation in a tinnitus treatment regimen within the past four weeks&#xD;
&#xD;
          -  Retrocochlear pathology/ VIIIth nerve lesion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Shore, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Kresge Hearing Research Institute</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <results_first_submitted>April 7, 2017</results_first_submitted>
  <results_first_submitted_qc>April 7, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 17, 2017</results_first_posted>
  <last_update_submitted>April 7, 2017</last_update_submitted>
  <last_update_submitted_qc>April 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Susan E. Shore</investigator_full_name>
    <investigator_title>Professor, Otolaryngology, Molecular and Integrative Physiology; Professor, Biomedical Engineering Kresge Hearing Research Institute The Joseph Hawkins Collegiate Research Professor</investigator_title>
  </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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>14 participants consented to the study, but were screened out of allocation to either arm for excess hearing loss, lack of somatosensory modulation, or unwillingness to participate (largely due to time committments/availability).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sham 1st (Auditory Only) Then Active (Bimodal)</title>
          <description>To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.&#xD;
During active treatment, the device will deliver electric somatosensory and auditory stimulation.&#xD;
Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.&#xD;
Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.&#xD;
The auditory stimulus will be individualized based on s</description>
        </group>
        <group group_id="P2">
          <title>Active (Bimodal) Then Sham (Auditory Only)</title>
          <description>During active treatment, the device will deliver electric somatosensory and auditory stimulation.&#xD;
To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.&#xD;
Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.&#xD;
Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.&#xD;
The auditory stimulus will be individualized based on s</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Began Washout Period</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Began Crossover Assignment</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline data are included only for those participants for whom outcome measure data was completed (N=20). One subject was consented and began the study, but withdrew after week one.</population>
      <group_list>
        <group group_id="B1">
          <title>Active 1st (Bimodal) Then Sham (Auditory Only)</title>
          <description>During active treatment the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.</description>
        </group>
        <group group_id="B2">
          <title>Sham 1st (Auditory Only) Then Active (Bimodal)</title>
          <description>To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.</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="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </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="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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_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="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </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="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tinnitus Functional Index (TFI)</title>
          <description>Baseline measure of TFI score. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact. This measure will be performed at baseline, as well as time points following active, washout, or sham periods.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.88" spread="16.70"/>
                    <measurement group_id="B2" value="26.66" spread="14.78"/>
                    <measurement group_id="B3" value="31.78" spread="16.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tinnitus Loudness</title>
          <description>Tinnitus matching loudness score at baseline assessment. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels/dB) they perceive their tinnitus to be (TinnTester). This measure will be performed at baseline, as well as time points following active, washout, or sham periods.</description>
          <units>dB</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.99" spread="14.77"/>
                    <measurement group_id="B2" value="49.85" spread="18.25"/>
                    <measurement group_id="B3" value="54.42" spread="14.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline</title>
        <description>Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.</description>
        <time_frame>Four weeks on treatment (or sham)</time_frame>
        <population>First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).</population>
        <group_list>
          <group group_id="O1">
            <title>Active Before Sham</title>
          </group>
          <group group_id="O2">
            <title>Washout After Active</title>
          </group>
          <group group_id="O3">
            <title>Sham After Active</title>
          </group>
          <group group_id="O4">
            <title>Sham Before Active</title>
          </group>
          <group group_id="O5">
            <title>Washout After Sham</title>
          </group>
          <group group_id="O6">
            <title>Active After Sham</title>
          </group>
        </group_list>
        <measure>
          <title>Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline</title>
          <description>Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.</description>
          <population>First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).</population>
          <units>units 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="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.08" spread="6.79"/>
                    <measurement group_id="O2" value="-5.40" spread="4.11"/>
                    <measurement group_id="O3" value="0.95" spread="10.32"/>
                    <measurement group_id="O4" value="-4.34" spread="4.11"/>
                    <measurement group_id="O5" value="-2.24" spread="4.58"/>
                    <measurement group_id="O6" value="-5.27" spread="6.46"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Tinnitus Loudness as Assessed by TinnTester</title>
        <description>Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.</description>
        <time_frame>4 weeks on treatment (or sham)</time_frame>
        <population>First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).</population>
        <group_list>
          <group group_id="O1">
            <title>Active Before Sham</title>
          </group>
          <group group_id="O2">
            <title>Washout After Active</title>
          </group>
          <group group_id="O3">
            <title>Sham After Active</title>
          </group>
          <group group_id="O4">
            <title>Sham Before Active</title>
          </group>
          <group group_id="O5">
            <title>Washout After Sham</title>
          </group>
          <group group_id="O6">
            <title>Active After Sham</title>
          </group>
        </group_list>
        <measure>
          <title>Change in Tinnitus Loudness as Assessed by TinnTester</title>
          <description>Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.</description>
          <population>First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).</population>
          <units>dB</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.25" spread="9.69"/>
                    <measurement group_id="O2" value="-1.52" spread="7.16"/>
                    <measurement group_id="O3" value="-3.17" spread="5.02"/>
                    <measurement group_id="O4" value="-3.34" spread="4.50"/>
                    <measurement group_id="O5" value="-1.67" spread="3.98"/>
                    <measurement group_id="O6" value="-7.85" spread="8.79"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks of treatment or sham</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active Before Sham</title>
        </group>
        <group group_id="E2">
          <title>Washout After Active</title>
        </group>
        <group group_id="E3">
          <title>Sham After Active</title>
        </group>
        <group group_id="E4">
          <title>Sham Before Active</title>
        </group>
        <group group_id="E5">
          <title>Washout After Sham</title>
        </group>
        <group group_id="E6">
          <title>Active After Sham</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </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>
    <point_of_contact>
      <name_or_title>Susan Shore, Professor of Otolaryngology</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734 647-2116</phone>
      <email>sushore@umich.edu</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/NCT02974543
org study id: HUM00088432
nct id: NCT02974543
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to develop and test a subject operated device to lessen tinnitus
      (ringing in the ear), based on subject-feedback for stimulus presentation.
This study consented 35 adult subjects. 21 subjects qualified and were randomized into the
      study. This project will develop and test a device with the ultimate goal of providing a
      patient operated device to alleviate phantom sound perception, or tinnitus, based on
      patient-feedback for stimulus presentation.

      The device, an electrical-acoustical stimulus timing, is based on physiological findings of
      stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant,
      contribute to tinnitus.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline
time frame: Four weeks on treatment (or sham)
description: Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.
measure: Change in Tinnitus Loudness as Assessed by TinnTester
time frame: 4 weeks on treatment (or sham)
description: Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.
arm group label: Sham 1st (Auditory only) then Active (Bimodal)
arm group type: Other
description: To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.
During active treatment, the device will deliver electric somatosensory and auditory stimulation.
arm group label: Active (Bimodal) then Sham (Auditory only)
arm group type: Other
description: During active treatment, the device will deliver electric somatosensory and auditory stimulation.
To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.
intervention type: Device
intervention name: Sham Treatment: unimodal auditory stimulation
description: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.
arm group label: Active (Bimodal) then Sham (Auditory only)
arm group label: Sham 1st (Auditory only) then Active (Bimodal)
intervention type: Device
intervention name: Active Treatment: Bimodal auditory-somatosensory stimulation
description: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.
The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.
arm group label: Active (Bimodal) then Sham (Auditory only)
arm group label: Sham 1st (Auditory only) then Active (Bimodal)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan Shore, Ph.D
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Susan E. Shore
investigator title: Professor, Otolaryngology, Molecular and Integrative Physiology; Professor, Biomedical Engineering Kresge Hearing Research Institute The Joseph Hawkins Collegiate Research Professor
mesh term: Tinnitus
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 