xml: <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/NCT05981391</url>
    </required_header>
    <id_info>
      <org_study_id>HSC20200573HU</org_study_id>
      <nct_id>NCT05981391</nct_id>
    </id_info>
    <brief_title>Neurobiological Similarities of Tinnitus and PTSD</brief_title>
    <official_title>An Evaluation of Neurobiological Similarities of Tinnitus and Posttraumatic Stress Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center at San Antonio</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hearing Center of Excellence</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Texas Health Science Center at San Antonio</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Psychiatric distress caused by PTSD may increase attention toward tinnitus, as well as&#xD;
        perceived loudness and discomfort. It is important to understand how tinnitus-related&#xD;
        distress and PTSD negatively interact together, in order to develop more effective&#xD;
        therapeutic approaches. Understanding symptoms and neurobiological mechanisms using&#xD;
        functional magnetic resonance imaging (fMRI), can lead to the necessary knowledge to develop&#xD;
        effective interventions for individuals who suffer from both conditions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Tinnitus and posttraumatic stress disorder (PTSD) are two of the most common&#xD;
        service-connected disabilities for active-duty Service Members and Veterans. Tinnitus and&#xD;
        PTSD are highly co-morbid, yet distinct disorders. Tinnitus is an auditory disorder in which&#xD;
        an illusory auditory percept is experienced, usually as ringing, buzzing, or whooshing&#xD;
        sounds, despite no external objective noise source. On the other hand, PTSD is a&#xD;
        trauma-related disorder, and is identified by intrusions of the traumatic event, avoidance of&#xD;
        reminders, negative alterations in cognition and mood, and hypervigilance or hyperarousal.&#xD;
        Similarities between tinnitus and PTSD have been documented among Cambodian refugees, as well&#xD;
        as among U.S. Veteran samples. Moreover, the latest neuroimaging data from a recent clinical&#xD;
        trial indicated that the auditory-vigilance network was the most dysregulated among&#xD;
        active-duty service members with PTSD, compared to combat controls and civilian controls. Due&#xD;
        to similar symptoms between tinnitus-related distress and PTSD, and similar dysregulated&#xD;
        resting-state brain networks, it remains important to more fully understand how these two&#xD;
        distinct disorders may be related. This study will be the first to prospectively examine the&#xD;
        overt emotional, behavioral, and cognitive symptoms related to tinnitus-related distress and&#xD;
        PTSD, and the overlapping functional connectivity between tinnitus and PTSD. Investigators&#xD;
        will examine the overlapping symptoms and neurobiological mechanisms by conducting&#xD;
        audiometric and psychological assessments and resting-state functional magnetic resonance&#xD;
        imaging (fMRI) among 120 participants (30 with tinnitus and PTSD, 30 with only PTSD, 30 with&#xD;
        only tinnitus, and 30 healthy controls). Participants will be recruited from the Frank Tejeda&#xD;
        PTSD Clinic and the Audiology Clinic within the South Texas VA Health Care System, and the&#xD;
        Hearing Center of Excellence at Lackland Air Force Base. Canonical correlations will be&#xD;
        conducted to examine the symptom overlap between tinnitus and PTSD (Aim 1). Investigators aim&#xD;
        to neurobiologically characterize tinnitus and PTSD, both separately and conjointly, by&#xD;
        conducting fMRI (Aim 2). Investigators also aim to apply modeling to psychometric and&#xD;
        neurofunctional data to identify specific regions of the auditory-vigilance network&#xD;
        associated with distress related to tinnitus and PTSD. Understanding the shared cognitive,&#xD;
        emotional, and behavioral symptoms and neurobiology associated with tinnitus and PTSD will&#xD;
        help clinicians and researchers fully understand tinnitus and PTSD independently and&#xD;
        conjointly. Results will lead to the identification of neurobiological markers for tinnitus&#xD;
        and PTSD, identification of a different phenotype for individuals with both conditions, and&#xD;
        development of behavioral and neuro-modulatory therapies that can reduce distress and&#xD;
        impairment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 4, 2021</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Resting-State Functional MRI</measure>
      <time_frame>30 minutes of acquired data</time_frame>
      <description>We will acquire BOLD fMRI images in an unstimulated state using an extended time-series (300 whole-brain volumes over ~ 60-75 min). These data are a main outcome. Data will be processed on an ongoing basis to ensure integrity, and includes controlling for white matter, cerebral spinal fluid, and movement.</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Posttraumatic Stress Disorder</condition>
    <condition>Tinnitus</condition>
    <arm_group>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
      <description>Active duty service members and/or veterans with PTSD and tinnitus.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tinnitus Only (TO)</arm_group_label>
      <description>Active duty service members and/or veterans with only tinnitus/no PTSD.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PTSD Only (PO)</arm_group_label>
      <description>Active duty service members and/or veterans with only PTSD/no tinnitus.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Controls</arm_group_label>
      <description>Active duty service members and/or veterans with no PTSD and no tinnitus.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>resting-state functional MRI</intervention_name>
      <description>We will acquire BOLD fMRI images in an unstimulated state using an extended time-series (300 whole-brain volumes over ~ 60-75 min). These data are a main outcome. Data will be processed on an ongoing basis to ensure integrity, and includes controlling for white matter, cerebral spinal fluid, and movement.</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>PTSD Only (PO)</arm_group_label>
      <arm_group_label>Tinnitus Only (TO)</arm_group_label>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)</intervention_name>
      <description>The CAPS-5 is a semi-structured interview, conducted by an independent evaluator, that measures DSM-5 symptoms of PTSD. Presence of at least one intrusion symptom, one avoidance symptom, two cognition and mood symptoms, and two arousal symptoms for 1 month or more are required to reach the diagnostic threshold.</description>
      <arm_group_label>PTSD Only (PO)</arm_group_label>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Tympanometry</intervention_name>
      <description>Tympanometry will be conducted to assess ear canal volume (cm cubed), maximum pressure (daPa) peak compliance (ml), and type (A, AD, AS, B, B-High, C) for each ear) at 226-Hz admittance.</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>PTSD Only (PO)</arm_group_label>
      <arm_group_label>Tinnitus Only (TO)</arm_group_label>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Tinnitus Assessment</intervention_name>
      <description>Tinnitus acoustic assessment (for tinnitus participants only): Tinnitus ear (left, right, bilateral), pitch matched frequency (Hz) and loudness matched intensity (dB) will be conducted. When available, the tinnitus acoustic assessment only will be repeated at the RII, on the same day and prior to the fMRI scan, to demonstrate reproducibility of results.</description>
      <arm_group_label>Tinnitus Only (TO)</arm_group_label>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Otoscopy</intervention_name>
      <description>Otoscopy is a clinical procedure used to examine structures of the ear, particularly the external auditory canal, tympanic membrane, and middle ear</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>PTSD Only (PO)</arm_group_label>
      <arm_group_label>Tinnitus Only (TO)</arm_group_label>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Pure tone air and bone-conduction</intervention_name>
      <description>Pure tone air- and bone-conduction threshold will be conducted to evaluate audiometry and masking levels in both ears, from 250 Hz. To 16000 Hz.</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>PTSD Only (PO)</arm_group_label>
      <arm_group_label>Tinnitus Only (TO)</arm_group_label>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Speech testing</intervention_name>
      <description>Speech testing will be conducted in both ears, which will include speech reception threshold, speech reception threshold masking level, word recognition presentation level, and word recognition masking level.</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>PTSD Only (PO)</arm_group_label>
      <arm_group_label>Tinnitus Only (TO)</arm_group_label>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Loudness Discomfort</intervention_name>
      <description>Loudness discomfort levels will be tested in both right and left ears, from 500Hz to 4000Hz and speech reception threshold.</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>PTSD Only (PO)</arm_group_label>
      <arm_group_label>Tinnitus Only (TO)</arm_group_label>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Quick Speech in Noise Test</intervention_name>
      <description>Quick Speech in Noise Test (QuickSIN) is a quick method for clinicians to quantify a patient's ability to hear in noise (1 minute).</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>PTSD Only (PO)</arm_group_label>
      <arm_group_label>Tinnitus Only (TO)</arm_group_label>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Distortion-Product Otoacoustic Emissions (DPOAE)</intervention_name>
      <description>Distortion-Product Otoacoustic Emissions (DPOAE) is an automated evaluation of cochlear function. A sensitive microphone is placed in the ear canal via a probe assembly with a disposable ear-tip attached to perform and record the measurements. DPOAEs will be elicited at multiple frequencies in both ears (10 min).</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>PTSD Only (PO)</arm_group_label>
      <arm_group_label>Tinnitus Only (TO)</arm_group_label>
      <arm_group_label>Tinnitus and PTSD (T+P)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study will consent and screen veterans and active duty service members to include 120&#xD;
          for analysis. Subjects will be recruited from the San Antonio community. Women and&#xD;
          minorities will be actively recruited into the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female DEERS eligible veterans and active duty service members, ages 18 and&#xD;
               above&#xD;
  &#xD;
            -  preferred language is English and able to read and speak English at a 6th grade level&#xD;
  &#xD;
            -  those with PTSD (T&amp;P; PO) must meet full criteria for PTSD diagnosis based on the&#xD;
               DSM-5 and assessed by an independent evaluator using the CAPS-5&#xD;
  &#xD;
            -  those with chronic, constant tinnitus (T&amp;P, TO) will be identified by self-report and&#xD;
               confirmed with the audiometric assessment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  psychiatric hospitalization in the last 12 months&#xD;
  &#xD;
            -  significant cognitive impairment determined by inability to comprehend screening&#xD;
               assessment&#xD;
  &#xD;
            -  psychiatric problems and/or high suicide risk warranting immediate intervention&#xD;
  &#xD;
            -  neurobiological disorders, Meniere's disease&#xD;
  &#xD;
            -  Temporomandibular disorders that affect tinnitus, per self-report&#xD;
  &#xD;
            -  history of major head trauma with loss of consciousness for 20 minutes or more as&#xD;
               determined by the History of Head Injuries questionnaire&#xD;
  &#xD;
            -  history of seizures&#xD;
  &#xD;
            -  conditions that would prevent completion of fMRI scan (any type of electronic,&#xD;
               mechanical, or magnetic implant, coil, filter, or stent, any type of surgical clip or&#xD;
               staple, shunt, any type of metal object, hearing aid, spinal fusion, halo vest, IV&#xD;
               access port, eyelid spring, artificial eye, artificial heart valve, biostimulator,&#xD;
               severe hyperacusis)&#xD;
  &#xD;
            -  active conductive pathology/hearing loss as determined by audiometric assessment.&#xD;
  &#xD;
            -  Those with tinnitus (T&amp;P; TO) will be excluded if their tinnitus is intermittent,&#xD;
               objective, or pulsatile, or present for less than 6 months.&#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>
    <location>
      <facility>
        <name>UT Health San Antonio</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amanda Flores, BA</last_name>
        <phone>210-562-6726</phone>
        <email>floresa13@uthscsa.edu</email>
      </contact>
      <investigator>
        <last_name>John Moring, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center at San Antonio</investigator_affiliation>
      <investigator_full_name>John Moring</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>resting-state fMRI</keyword>
    <keyword>PTSD</keyword>
    <keyword>tinnitus</keyword>
    <keyword>military</keyword>
    <keyword>veterans</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tinnitus</mesh_term>
      <mesh_term>Stress Disorders, Traumatic</mesh_term>
      <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981391
  org study id: HSC20200573HU
  nct id: NCT05981391
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Psychiatric distress caused by PTSD may increase attention toward tinnitus, as well as
        perceived loudness and discomfort. It is important to understand how tinnitus-related
        distress and PTSD negatively interact together, in order to develop more effective
        therapeutic approaches. Understanding symptoms and neurobiological mechanisms using
        functional magnetic resonance imaging (fMRI), can lead to the necessary knowledge to develop
        effective interventions for individuals who suffer from both conditions.
  Tinnitus and posttraumatic stress disorder (PTSD) are two of the most common
        service-connected disabilities for active-duty Service Members and Veterans. Tinnitus and
        PTSD are highly co-morbid, yet distinct disorders. Tinnitus is an auditory disorder in which
        an illusory auditory percept is experienced, usually as ringing, buzzing, or whooshing
        sounds, despite no external objective noise source. On the other hand, PTSD is a
        trauma-related disorder, and is identified by intrusions of the traumatic event, avoidance of
        reminders, negative alterations in cognition and mood, and hypervigilance or hyperarousal.
        Similarities between tinnitus and PTSD have been documented among Cambodian refugees, as well
        as among U.S. Veteran samples. Moreover, the latest neuroimaging data from a recent clinical
        trial indicated that the auditory-vigilance network was the most dysregulated among
        active-duty service members with PTSD, compared to combat controls and civilian controls. Due
        to similar symptoms between tinnitus-related distress and PTSD, and similar dysregulated
        resting-state brain networks, it remains important to more fully understand how these two
        distinct disorders may be related. This study will be the first to prospectively examine the
        overt emotional, behavioral, and cognitive symptoms related to tinnitus-related distress and
        PTSD, and the overlapping functional connectivity between tinnitus and PTSD. Investigators
        will examine the overlapping symptoms and neurobiological mechanisms by conducting
        audiometric and psychological assessments and resting-state functional magnetic resonance
        imaging (fMRI) among 120 participants (30 with tinnitus and PTSD, 30 with only PTSD, 30 with
        only tinnitus, and 30 healthy controls). Participants will be recruited from the Frank Tejeda
        PTSD Clinic and the Audiology Clinic within the South Texas VA Health Care System, and the
        Hearing Center of Excellence at Lackland Air Force Base. Canonical correlations will be
        conducted to examine the symptom overlap between tinnitus and PTSD (Aim 1). Investigators aim
        to neurobiologically characterize tinnitus and PTSD, both separately and conjointly, by
        conducting fMRI (Aim 2). Investigators also aim to apply modeling to psychometric and
        neurofunctional data to identify specific regions of the auditory-vigilance network
        associated with distress related to tinnitus and PTSD. Understanding the shared cognitive,
        emotional, and behavioral symptoms and neurobiology associated with tinnitus and PTSD will
        help clinicians and researchers fully understand tinnitus and PTSD independently and
        conjointly. Results will lead to the identification of neurobiological markers for tinnitus
        and PTSD, identification of a different phenotype for individuals with both conditions, and
        development of behavioral and neuro-modulatory therapies that can reduce distress and
        impairment.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Resting-State Functional MRI
  time frame: 30 minutes of acquired data
  description: We will acquire BOLD fMRI images in an unstimulated state using an extended time-series (300 whole-brain volumes over ~ 60-75 min). These data are a main outcome. Data will be processed on an ongoing basis to ensure integrity, and includes controlling for white matter, cerebral spinal fluid, and movement.
  arm group label: Tinnitus and PTSD (T+P)
  description: Active duty service members and/or veterans with PTSD and tinnitus.
  arm group label: Tinnitus Only (TO)
  description: Active duty service members and/or veterans with only tinnitus/no PTSD.
  arm group label: PTSD Only (PO)
  description: Active duty service members and/or veterans with only PTSD/no tinnitus.
  arm group label: Healthy Controls
  description: Active duty service members and/or veterans with no PTSD and no tinnitus.
  intervention type: Diagnostic Test
  intervention name: resting-state functional MRI
  description: We will acquire BOLD fMRI images in an unstimulated state using an extended time-series (300 whole-brain volumes over ~ 60-75 min). These data are a main outcome. Data will be processed on an ongoing basis to ensure integrity, and includes controlling for white matter, cerebral spinal fluid, and movement.
  arm group label: Healthy Controls
  arm group label: PTSD Only (PO)
  arm group label: Tinnitus Only (TO)
  arm group label: Tinnitus and PTSD (T+P)
  intervention type: Diagnostic Test
  intervention name: Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)
  description: The CAPS-5 is a semi-structured interview, conducted by an independent evaluator, that measures DSM-5 symptoms of PTSD. Presence of at least one intrusion symptom, one avoidance symptom, two cognition and mood symptoms, and two arousal symptoms for 1 month or more are required to reach the diagnostic threshold.
  arm group label: PTSD Only (PO)
  arm group label: Tinnitus and PTSD (T+P)
  intervention type: Diagnostic Test
  intervention name: Tympanometry
  description: Tympanometry will be conducted to assess ear canal volume (cm cubed), maximum pressure (daPa) peak compliance (ml), and type (A, AD, AS, B, B-High, C) for each ear) at 226-Hz admittance.
  arm group label: Healthy Controls
  arm group label: PTSD Only (PO)
  arm group label: Tinnitus Only (TO)
  arm group label: Tinnitus and PTSD (T+P)
  intervention type: Diagnostic Test
  intervention name: Tinnitus Assessment
  description: Tinnitus acoustic assessment (for tinnitus participants only): Tinnitus ear (left, right, bilateral), pitch matched frequency (Hz) and loudness matched intensity (dB) will be conducted. When available, the tinnitus acoustic assessment only will be repeated at the RII, on the same day and prior to the fMRI scan, to demonstrate reproducibility of results.
  arm group label: Tinnitus Only (TO)
  arm group label: Tinnitus and PTSD (T+P)
  intervention type: Diagnostic Test
  intervention name: Otoscopy
  description: Otoscopy is a clinical procedure used to examine structures of the ear, particularly the external auditory canal, tympanic membrane, and middle ear
  arm group label: Healthy Controls
  arm group label: PTSD Only (PO)
  arm group label: Tinnitus Only (TO)
  arm group label: Tinnitus and PTSD (T+P)
  intervention type: Diagnostic Test
  intervention name: Pure tone air and bone-conduction
  description: Pure tone air- and bone-conduction threshold will be conducted to evaluate audiometry and masking levels in both ears, from 250 Hz. To 16000 Hz.
  arm group label: Healthy Controls
  arm group label: PTSD Only (PO)
  arm group label: Tinnitus Only (TO)
  arm group label: Tinnitus and PTSD (T+P)
  intervention type: Diagnostic Test
  intervention name: Speech testing
  description: Speech testing will be conducted in both ears, which will include speech reception threshold, speech reception threshold masking level, word recognition presentation level, and word recognition masking level.
  arm group label: Healthy Controls
  arm group label: PTSD Only (PO)
  arm group label: Tinnitus Only (TO)
  arm group label: Tinnitus and PTSD (T+P)
  intervention type: Diagnostic Test
  intervention name: Loudness Discomfort
  description: Loudness discomfort levels will be tested in both right and left ears, from 500Hz to 4000Hz and speech reception threshold.
  arm group label: Healthy Controls
  arm group label: PTSD Only (PO)
  arm group label: Tinnitus Only (TO)
  arm group label: Tinnitus and PTSD (T+P)
  intervention type: Diagnostic Test
  intervention name: Quick Speech in Noise Test
  description: Quick Speech in Noise Test (QuickSIN) is a quick method for clinicians to quantify a patient's ability to hear in noise (1 minute).
  arm group label: Healthy Controls
  arm group label: PTSD Only (PO)
  arm group label: Tinnitus Only (TO)
  arm group label: Tinnitus and PTSD (T+P)
  intervention type: Diagnostic Test
  intervention name: Distortion-Product Otoacoustic Emissions (DPOAE)
  description: Distortion-Product Otoacoustic Emissions (DPOAE) is an automated evaluation of cochlear function. A sensitive microphone is placed in the ear canal via a probe assembly with a disposable ear-tip attached to perform and record the measurements. DPOAEs will be elicited at multiple frequencies in both ears (10 min).
  arm group label: Healthy Controls
  arm group label: PTSD Only (PO)
  arm group label: Tinnitus Only (TO)
  arm group label: Tinnitus and PTSD (T+P)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center at San Antonio
  investigator full name: John Moring
  investigator title: Assistant Professor
  mesh term: Tinnitus
  mesh term: Stress Disorders, Traumatic
  mesh term: Stress Disorders, Post-Traumatic