<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20231016059744N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-20</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating Effect of Acoustic Coordinated Reset on Tinnitus Handicap and Loudness Discomfort level</public_title>
      <acronym></acronym>
      <scientific_title>Creating of Acoustic Coordinated Reset Neuromodulation Application and Investigating Its Effects on Tinnitus Handicap and Loudness Discomfort Level in Tinnitus Patients With and Without Hyperacusis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81409</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Tinnitus. Condition 2: Hyperacusis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Individuals with Tinnitus Receiving Sound Therapy Using the Acoustic Coordinated Reset Method for Three Months and 3 Hours a Day. Acoustic Coordinated Reset Consists of Four Pure Tones Around the Individual's Tinnitus Frequency, Which are Created According to a Specific Algorithm Based on The Tonotopic Arrangement of the Auditory Cortex. This Method Consists of Three Cycles, Each of Which has Tones in a Different Order, Followed by Two Cycles of Silence or Pause, and This Pattern is Repeated. The Person with Tinnitus must Listen to This Sounds for a Certain Amount of Time Daily, and the Ultimate Goal of this Method is to Counteract Abnormal Neural Synchronization. Intervention 2: Intervention group 2: Individuals with Tinnitus and Hyperacusis Receiving Sound Therapy Using the Acoustic Coordinated Reset Method for Three Months. Acoustic Coordinated Reset Consists of Four Pure Tones Around the Individual's Tinnitus Frequency, Which are Created According to a Specific Algorithm Based on The Tonotopic Arrangement of the Auditory Cortex. This Method Consists of Three Cycles, Each of Which has Tones in a Different Order, Followed by Two Cycles of Silence or Pause, and This Pattern is Repeated. The Person with Tinnitus must Listen to This Sounds for a Certain Amount of Time Daily, and the Ultimate Goal of this Method is to Counteract Abnormal Neural Synchronization.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Sadeghijam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madadkaran St., Shahnazari Ave., Madar Squ., Mirdamad Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>sadeghijam.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Sadeghijam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madadkaran St., Shahnazari Ave., Madar Squ., Mirdamad Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>sadeghijam.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals must have Chronic Tinnitus (have Experienced Tinnitus for Over 6 Months)
Tinnitus should be Tonal
Participants Pure Tone Audiometric Thresholds can Range from Normal Hearing to Mild to Moderate Hearing Loss (Thresholds Better than 40 dB HL)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals must not have any Neurological Disorders ( History of Head Trauma, Acoustic Neuroma, MS,...) and Otologic Diseases (Meniere, Otosclerosis, Otitis,...)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H93.1</hc_code>
      <hc_code>H93.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tinnitus</hc_keyword>
      <hc_keyword>Other abnormal auditory perceptions</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Individuals with Tinnitus Receiving Sound Therapy Using the Acoustic Coordinated Reset Method for Three Months and 3 Hours a Day. Acoustic Coordinated Reset Consists of Four Pure Tones Around the Individual's Tinnitus Frequency, Which are Created According to a Specific Algorithm Based on The Tonotopic Arrangement of the Auditory Cortex. This Method Consists of Three Cycles, Each of Which has Tones in a Different Order, Followed by Two Cycles of Silence or Pause, and This Pattern is Repeated. The Person with Tinnitus must Listen to This Sounds for a Certain Amount of Time Daily, and the Ultimate Goal of this Method is to Counteract Abnormal Neural Synchronization.</i_keyword>
      <i_keyword>Intervention group 2: Individuals with Tinnitus and Hyperacusis Receiving Sound Therapy Using the Acoustic Coordinated Reset Method for Three Months. Acoustic Coordinated Reset Consists of Four Pure Tones Around the Individual's Tinnitus Frequency, Which are Created According to a Specific Algorithm Based on The Tonotopic Arrangement of the Auditory Cortex. This Method Consists of Three Cycles, Each of Which has Tones in a Different Order, Followed by Two Cycles of Silence or Pause, and This Pattern is Repeated. The Person with Tinnitus must Listen to This Sounds for a Certain Amount of Time Daily, and the Ultimate Goal of this Method is to Counteract Abnormal Neural Synchronization.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tinnitus Loudness (dB SL). Timepoint: Measurement of Tinnitus Loudness Before the Start of the Intervention and at the End of the Three Month Treatment Period. Method of measurement: Psychoacoustic Tinnitus Measurement.</prim_outcome>
      <prim_outcome>Tinnitus Loudness. Timepoint: Measurement of Index Score Before the Start of the Intervention and at the End of the Three Month Treatment Period. Method of measurement: Visual-Analogue Index of Loudness.</prim_outcome>
      <prim_outcome>Tinnitus Annoyance. Timepoint: Measurement of Index Score Before the Start of the Intervention and at the End of the Three Month Treatment Period. Method of measurement: Visual Analogue Index of Annoyance.</prim_outcome>
      <prim_outcome>Tinnitus Handicap Index Questionnaire Score. Timepoint: Measurement of Questionnaire Score Before the Start of the Intervention and at the End of the Three Month Treatment Period. Method of measurement: Tinnitus Handicap Index Questionnaire.</prim_outcome>
      <prim_outcome>Khalfa Hyperacusis Questionnaire Score. Timepoint: Measurement of Questionnaire Score Before the Start of the Intervention and at the End of the Three Month Treatment Period. Method of measurement: Khalfa Hyperacusis Questionnaire.</prim_outcome>
      <prim_outcome>Tinnitus Frequency. Timepoint: Measurement of Tinnitus Frequency Before the Start of the Intervention and at the End of the Three Month Treatment Period. Method of measurement: Psychoacoustic Tinnitus Measurement.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-03</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Shahid Hemmat Highway, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
