<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/NCT04449237</url>
  </required_header>
  <id_info>
    <org_study_id>sunshan</org_study_id>
    <nct_id>NCT04449237</nct_id>
  </id_info>
  <brief_title>Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention</brief_title>
  <acronym>EEG-RCT</acronym>
  <official_title>The Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eye &amp; ENT Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eye &amp; ENT Hospital of Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This project aims to systematically and deeply study the central mechanism of tinnitus using&#xD;
      electroencephalogram, and further study the treatment mechanism of tinnitus in combination&#xD;
      with sound treatment strategies, so as to provide a research basis for clinical treatment of&#xD;
      tinnitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tinnitus is one of the most common auditory disturbances in human. The treatment of tinnitus&#xD;
      is always not effective, and the standardized treatment of tinnitus has been lacking. With&#xD;
      the development of neuroimaging, neuroelectrophysiology and animal models of tinnitus, the&#xD;
      central mechanism of tinnitus has been gradually revealed. The possible mechanisms of&#xD;
      tinnitus are the increase of spontaneous discharge rate and synchronization of auditory&#xD;
      central neurons caused by hearing deprivation, the change of brain topological structure, the&#xD;
      reorganization of auditory cortex, and the disorder of limbic system and auditory central&#xD;
      regulation of tinnitus patients. EEG, as an important means to study the cerebral cortex, has&#xD;
      become an important technical support for the research on the central mechanism of tinnitus.&#xD;
      Changes in activity in auditory brain areas associated with tinnitus have been observed using&#xD;
      EEG/ERPs, and non-auditory brain areas such as the limbic system and frontal cortices have&#xD;
      also been associated with tinnitus mechanisms. This project aims to systematically and deeply&#xD;
      study the central mechanism of tinnitus using electroencephalogram, and further study the&#xD;
      treatment mechanism of tinnitus in combination with sound treatment strategies, so as to&#xD;
      provide a research basis for clinical treatment of tinnitus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>electroencephalogram evaluation</measure>
    <time_frame>From date of randomization, assessed every 3 month, up to 24 month</time_frame>
    <description>latency</description>
  </primary_outcome>
  <primary_outcome>
    <measure>electroencephalogram evaluation</measure>
    <time_frame>From date of randomization, assessed every 3 month, up to 24 month</time_frame>
    <description>peak</description>
  </primary_outcome>
  <primary_outcome>
    <measure>electroencephalogram evaluation</measure>
    <time_frame>From date of randomization, assessed every 3 month, up to 24 month</time_frame>
    <description>amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the loudness of tinnitus</measure>
    <time_frame>From date of randomization, assessed every 3 month, up to 24 month</time_frame>
    <description>estimated by auditory facility, recorded by unit of dB</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the frequency of tinnitus</measure>
    <time_frame>From date of randomization, assessed every 3 month, up to 24 month</time_frame>
    <description>estimated by auditory facility, recorded by unit of Hz</description>
  </primary_outcome>
  <primary_outcome>
    <measure>minimum masking level</measure>
    <time_frame>From date of randomization, assessed every 3 month, up to 24 month</time_frame>
    <description>the minimum volume to masking tinnitus, recorded by unit of dB</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tinnitus Handicapped Inventory</measure>
    <time_frame>From date of randomization, assessed every 3 month, up to 24 month</time_frame>
    <description>Tinnitus disability is divided into four levels, the first level:&#xD;
0-16 points, no disability; Level 2:18-36, slightly disabled; Level 3:38-56, moderate disability; Level 4:58-100, severe disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety and Distress Scale</measure>
    <time_frame>From date of randomization, assessed every 3 month, up to 24 month</time_frame>
    <description>0-7 are asymptomatic; 8 -10 respectively belong to suspicious existence; 11 -21 must exist.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Tinnitus, Subjective</condition>
  <arm_group>
    <arm_group_label>volunteer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>40 volunteer will not accept any treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with unmodified music group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>40 participants in this group will listen to music without any modification</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with modified tinnitus relieving music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>music therapy</intervention_name>
    <description>music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.</description>
    <arm_group_label>patients with modified tinnitus relieving music</arm_group_label>
    <arm_group_label>patients with unmodified music group</arm_group_label>
    <arm_group_label>volunteer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-30 years old, male or female;&#xD;
&#xD;
          2. PTA (0.5,1,2kHz) ≤25dB HL;&#xD;
&#xD;
          3. Tinnitus is a major problem faced by patients (except healthy volunteers);&#xD;
&#xD;
          4. tinnitus course &gt; for 3 months;&#xD;
&#xD;
          5. Healthy, no history of other ear diseases, no history of hearing impairment;&#xD;
&#xD;
          6. There are no other medical, psychological or social problems that need urgent&#xD;
             treatment, and no other problems that interfere with tinnitus-related treatment;&#xD;
&#xD;
          7. Voluntary tinnitus treatment, and have enough time to cooperate with treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pulsatile tinnitus;&#xD;
&#xD;
          2. Acute tinnitus;&#xD;
&#xD;
          3. Tinnitus is associated with severe hearing loss;&#xD;
&#xD;
          4. Tinnitus accompanied by vertigo;&#xD;
&#xD;
          5. Tinnitus accompanied by headache;&#xD;
&#xD;
          6. Tinnitus is accompanied by somatic symptoms, such as neck pain and temporomandibular&#xD;
             joint disorder;&#xD;
&#xD;
          7. Post-traumatic tinnitus;&#xD;
&#xD;
          8. Tinnitus is associated with serious psychiatric complications;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04449237
org study id: sunshan
nct id: NCT04449237
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project aims to systematically and deeply study the central mechanism of tinnitus using
      electroencephalogram, and further study the treatment mechanism of tinnitus in combination
      with sound treatment strategies, so as to provide a research basis for clinical treatment of
      tinnitus.
Tinnitus is one of the most common auditory disturbances in human. The treatment of tinnitus
      is always not effective, and the standardized treatment of tinnitus has been lacking. With
      the development of neuroimaging, neuroelectrophysiology and animal models of tinnitus, the
      central mechanism of tinnitus has been gradually revealed. The possible mechanisms of
      tinnitus are the increase of spontaneous discharge rate and synchronization of auditory
      central neurons caused by hearing deprivation, the change of brain topological structure, the
      reorganization of auditory cortex, and the disorder of limbic system and auditory central
      regulation of tinnitus patients. EEG, as an important means to study the cerebral cortex, has
      become an important technical support for the research on the central mechanism of tinnitus.
      Changes in activity in auditory brain areas associated with tinnitus have been observed using
      EEG/ERPs, and non-auditory brain areas such as the limbic system and frontal cortices have
      also been associated with tinnitus mechanisms. This project aims to systematically and deeply
      study the central mechanism of tinnitus using electroencephalogram, and further study the
      treatment mechanism of tinnitus in combination with sound treatment strategies, so as to
      provide a research basis for clinical treatment of tinnitus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: electroencephalogram evaluation
time frame: From date of randomization, assessed every 3 month, up to 24 month
description: latency
measure: electroencephalogram evaluation
time frame: From date of randomization, assessed every 3 month, up to 24 month
description: peak
measure: electroencephalogram evaluation
time frame: From date of randomization, assessed every 3 month, up to 24 month
description: amplitude
measure: the loudness of tinnitus
time frame: From date of randomization, assessed every 3 month, up to 24 month
description: estimated by auditory facility, recorded by unit of dB
measure: the frequency of tinnitus
time frame: From date of randomization, assessed every 3 month, up to 24 month
description: estimated by auditory facility, recorded by unit of Hz
measure: minimum masking level
time frame: From date of randomization, assessed every 3 month, up to 24 month
description: the minimum volume to masking tinnitus, recorded by unit of dB
measure: Tinnitus Handicapped Inventory
time frame: From date of randomization, assessed every 3 month, up to 24 month
description: Tinnitus disability is divided into four levels, the first level:
0-16 points, no disability; Level 2:18-36, slightly disabled; Level 3:38-56, moderate disability; Level 4:58-100, severe disability.
measure: Hospital Anxiety and Distress Scale
time frame: From date of randomization, assessed every 3 month, up to 24 month
description: 0-7 are asymptomatic; 8 -10 respectively belong to suspicious existence; 11 -21 must exist.
arm group label: volunteer
arm group type: Other
description: 40 volunteer will not accept any treatment
arm group label: patients with unmodified music group
arm group type: Placebo Comparator
description: 40 participants in this group will listen to music without any modification
arm group label: patients with modified tinnitus relieving music
arm group type: Experimental
description: 40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch
intervention type: Other
intervention name: music therapy
description: music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.
arm group label: patients with modified tinnitus relieving music
arm group label: patients with unmodified music group
arm group label: volunteer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Tinnitus
sharing ipd: No