<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/NCT02191592</url>
  </required_header>
  <id_info>
    <org_study_id>201407024</org_study_id>
    <nct_id>NCT02191592</nct_id>
  </id_info>
  <brief_title>EMA-Defined Tinnitus Subgroups</brief_title>
  <official_title>Identification of Unique Tinnitus Subgroups Using Ecological Momentary Assessment (EMA).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to test a new way of measuring the severity of tinnitus&#xD;
      using a tool called Ecological Momentary Assessment (EMA) of Tinnitus. We will compare the&#xD;
      relationship with this tool with another widely used questionnaire. Previous studies we have&#xD;
      done suggest there are different patterns of tinnitus bother; we plan to explore how often&#xD;
      these patterns occur, and how many patterns of tinnitus bother there are. And lastly we want&#xD;
      to test how reliable this type of testing is for measuring the amount of bother people&#xD;
      experience from their tinnitus.&#xD;
&#xD;
      Hypothesis 1: We will be able to identify 6 or more distinctive patterns of tinnitus.&#xD;
&#xD;
      Hypothesis 2: EMA will provide a reliable method for more accurately capturing the amount of&#xD;
      bother individuals have from tinnitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      You to need to complete this brief survey to determine if you meet the criteria for&#xD;
      participation in the study. You are free to skip any questions that you prefer not to answer.&#xD;
      We will only use the information you provide in this survey to determine if you qualify for&#xD;
      the EMA-Defined Tinnitus Subgroups study.&#xD;
&#xD;
      To be in this study, you will be required to have a smart phone that can receive text&#xD;
      messages, is connected to the internet, and will allow you to connect via the internet to a&#xD;
      Washington University secure server. It is necessary to connect to the Washington University&#xD;
      server in order to complete a short survey four times a day for two separate two-week&#xD;
      periods.&#xD;
&#xD;
      The study involves us sending you text messages at 4 random times during the day, between the&#xD;
      hours of 8: 00 am - 9: 00 pm. The texts prompt you to click on a link and respond to a short&#xD;
      EMA survey regarding what you are doing, what your environment is, and how your tinnitus is&#xD;
      at that moment. These text messages will be sent daily for two weeks. Then you will have two&#xD;
      weeks off. Finally you will again receive the text messages asking for you to respond to the&#xD;
      survey for two more weeks. You will receive a total of 112 text messages over four weeks. In&#xD;
      addition we will send you four emails or texts asking you to complete a survey at the&#xD;
      following times: before you complete your first set of EMA surveys, at the end of the first&#xD;
      set EMA surveys, prior to starting the second set of EMA surveys, and a final time after you&#xD;
      have completed the final EMA survey. This study requires no visits to Washington University.&#xD;
&#xD;
      In order to participate you must complete this short prescreening survey to see if you&#xD;
      qualify.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Weeks</target_duration>
  <primary_outcome>
    <measure>Ecological Momentary Assessment of Tinnitus</measure>
    <time_frame>Week 1-2 and Week 4-6</time_frame>
    <description>This is a two week period of capturing real time data regarding a subjects tinnitus bother, environment, and activity at random periods of the day. This is a patient self report measure, but captures data in real time vs. asking them to recall information retrospectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tinnitus Functional Index (TFI)</measure>
    <time_frame>Pre-Screening, Baseline, Week 2, Week 4, Week 6</time_frame>
    <description>This is a retrospective patient self-report questionnaire. It scores the severity of patient bother experienced from their tinnitus.</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Tinnitus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from Otolaryngology Clinics and from Tinnitus Support Groups&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between the ages of 21 and 80.&#xD;
&#xD;
          -  Have subjective, unilateral or bilateral, tinnitus of 6 months' duration or longer.&#xD;
&#xD;
          -  Must be score of 1, 2, 3, or 4 on Global Bother Score. (Range is 0-4, with 0 being not&#xD;
             bothered and 4 being extremely bothered)&#xD;
&#xD;
          -  Must have access to a smart phone device compatible with the notification system.&#xD;
&#xD;
          -  Must be able to read, write, and understand English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tinnitus related to Workman's Compensation Claim or other litigation-related&#xD;
             situations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://otooutcomes.wustl.edu</url>
    <description>Clinical Outcomes Research Office Web-site</description>
  </link>
  <link>
    <url>http://j.mp/1sY0uHK</url>
    <description>Link to the pre-screening survey</description>
  </link>
  <reference>
    <citation>Stone AA, Shiffman S. Capturing momentary, self-report data: a proposal for reporting guidelines. Ann Behav Med. 2002 Summer;24(3):236-43. doi: 10.1207/S15324796ABM2403_09.</citation>
    <PMID>12173681</PMID>
  </reference>
  <reference>
    <citation>Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.</citation>
    <PMID>18509902</PMID>
  </reference>
  <reference>
    <citation>Freedman MJ, Lester KM, McNamara C, Milby JB, Schumacher JE. Cell phones for ecological momentary assessment with cocaine-addicted homeless patients in treatment. J Subst Abuse Treat. 2006 Mar;30(2):105-11. doi: 10.1016/j.jsat.2005.10.005.</citation>
    <PMID>16490673</PMID>
  </reference>
  <reference>
    <citation>Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0. Erratum In: Ear Hear. 2012 May;33(3):443.</citation>
    <PMID>22156949</PMID>
  </reference>
  <reference>
    <citation>Stone AA, Schwartz JE, Broderick JE, Shiffman SS. Variability of momentary pain predicts recall of weekly pain: a consequence of the peak (or salience) memory heuristic. Pers Soc Psychol Bull. 2005 Oct;31(10):1340-6. doi: 10.1177/0146167205275615.</citation>
    <PMID>16143666</PMID>
  </reference>
  <reference>
    <citation>Axelsson A, Ringdahl A. Tinnitus--a study of its prevalence and characteristics. Br J Audiol. 1989 Feb;23(1):53-62. doi: 10.3109/03005368909077819.</citation>
    <PMID>2784987</PMID>
  </reference>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>March 1, 2016</last_update_submitted>
  <last_update_submitted_qc>March 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Jay F. Piccirillo, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Tinnitus</keyword>
  <keyword>EMA</keyword>
  <keyword>Bothersome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</mesh_term>
  </condition_browse>
  <!-- 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/NCT02191592
org study id: 201407024
nct id: NCT02191592
lead sponsor: 
has dmc: No
The purpose of this research study is to test a new way of measuring the severity of tinnitus
      using a tool called Ecological Momentary Assessment (EMA) of Tinnitus. We will compare the
      relationship with this tool with another widely used questionnaire. Previous studies we have
      done suggest there are different patterns of tinnitus bother; we plan to explore how often
      these patterns occur, and how many patterns of tinnitus bother there are. And lastly we want
      to test how reliable this type of testing is for measuring the amount of bother people
      experience from their tinnitus.

      Hypothesis 1: We will be able to identify 6 or more distinctive patterns of tinnitus.

      Hypothesis 2: EMA will provide a reliable method for more accurately capturing the amount of
      bother individuals have from tinnitus.
You to need to complete this brief survey to determine if you meet the criteria for
      participation in the study. You are free to skip any questions that you prefer not to answer.
      We will only use the information you provide in this survey to determine if you qualify for
      the EMA-Defined Tinnitus Subgroups study.

      To be in this study, you will be required to have a smart phone that can receive text
      messages, is connected to the internet, and will allow you to connect via the internet to a
      Washington University secure server. It is necessary to connect to the Washington University
      server in order to complete a short survey four times a day for two separate two-week
      periods.

      The study involves us sending you text messages at 4 random times during the day, between the
      hours of 8: 00 am - 9: 00 pm. The texts prompt you to click on a link and respond to a short
      EMA survey regarding what you are doing, what your environment is, and how your tinnitus is
      at that moment. These text messages will be sent daily for two weeks. Then you will have two
      weeks off. Finally you will again receive the text messages asking for you to respond to the
      survey for two more weeks. You will receive a total of 112 text messages over four weeks. In
      addition we will send you four emails or texts asking you to complete a survey at the
      following times: before you complete your first set of EMA surveys, at the end of the first
      set EMA surveys, prior to starting the second set of EMA surveys, and a final time after you
      have completed the final EMA survey. This study requires no visits to Washington University.

      In order to participate you must complete this short prescreening survey to see if you
      qualify.
observational model: Case-Only
time perspective: Prospective
measure: Ecological Momentary Assessment of Tinnitus
time frame: Week 1-2 and Week 4-6
description: This is a two week period of capturing real time data regarding a subjects tinnitus bother, environment, and activity at random periods of the day. This is a patient self report measure, but captures data in real time vs. asking them to recall information retrospectively.
measure: Tinnitus Functional Index (TFI)
time frame: Pre-Screening, Baseline, Week 2, Week 4, Week 6
description: This is a retrospective patient self-report questionnaire. It scores the severity of patient bother experienced from their tinnitus.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
url: http://otooutcomes.wustl.edu
description: Clinical Outcomes Research Office Web-site
url: http://j.mp/1sY0uHK
description: Link to the pre-screening survey
citation: Stone AA, Shiffman S. Capturing momentary, self-report data: a proposal for reporting guidelines. Ann Behav Med. 2002 Summer;24(3):236-43. doi: 10.1207/S15324796ABM2403_09.
PMID: 12173681
citation: Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
PMID: 18509902
citation: Freedman MJ, Lester KM, McNamara C, Milby JB, Schumacher JE. Cell phones for ecological momentary assessment with cocaine-addicted homeless patients in treatment. J Subst Abuse Treat. 2006 Mar;30(2):105-11. doi: 10.1016/j.jsat.2005.10.005.
PMID: 16490673
citation: Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0. Erratum In: Ear Hear. 2012 May;33(3):443.
PMID: 22156949
citation: Stone AA, Schwartz JE, Broderick JE, Shiffman SS. Variability of momentary pain predicts recall of weekly pain: a consequence of the peak (or salience) memory heuristic. Pers Soc Psychol Bull. 2005 Oct;31(10):1340-6. doi: 10.1177/0146167205275615.
PMID: 16143666
citation: Axelsson A, Ringdahl A. Tinnitus--a study of its prevalence and characteristics. Br J Audiol. 1989 Feb;23(1):53-62. doi: 10.3109/03005368909077819.
PMID: 2784987
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Jay F. Piccirillo, MD
investigator title: Professor
mesh term: Tinnitus