<?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>IRCT20230513058159N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-30</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The combined effect of customized sound therapy and transcranial current stimulation in tinnitus sufferers</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of combined methods according to the cortical hubs in the tinnitus networks on improvement of loudness-annoyance and cognitive-auditory processing in tinnitus sufferers with hearing loss.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70078</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For random allocation, six blocks of 8, AABB، ABAB، ABBA، BBAA، BAAB, BABA  will be prepared and placed in envelopes in order of entry of the persons, one of the envelopes was selected at random, and based on the obtained block 4 patients will be assigned into 2 groups, Blinding description: in each clinical trial design, 3 groups can influence the results of the study. experiments, researcher, evaluated, or analyst. in this study, by randomly selecting participants in 2 groups and applying 2 different independent variables to each group which is blinded to the type of intervention that received. also the analyst of EEG and statistic are not ewer of the kind of intervention in the groups and they become practically blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: tinnitus. Condition 2: hearing loss.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A- customize sound therapy will be provided together with LTA transcranial direct current stimulation (tDCS) for 20 min  , the current intensity of 2 mA will be applied 6 sessions (3 sessions per week ). Intervention 2: Intervention group: Intervention group: Group A- customize sound therapy will be provided together with DLPFC  transcranial direct current stimulation (tDCS) for 20 min  , the current intensity of 2 mA will be applied 6 sessions (3 sessions per week ).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is We will publish it if necessary</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Manoosh Sobhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave., Daneshjo Blvd., Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 7371 3228</telephone>
        <email>manooshsobhany@gamil.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohana Javanbakht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave., Daneshjo Blvd., Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 7371 3228</telephone>
        <email>m.javanbakht@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>sufferers with chronic and subjective tinnitus  aged between 25-55 years
the average hearing threshold are between 20-60 in frequencies between 2-8 KHz in at least  1 hear
acoustic coverability of tinnitus
not using hearingAIDS and not perfuming paralleled drug and non drug treatment at the same time as this research
non-intensification of tinnitus in a residual inhibition assessment
absence of pulsatile  or multitone tinnitus
absence of Meniere's disease or any fluctuation in hearing level
absence of conductive and severe to profound hearing lost and obvious complaint of hyperacusis
earn maximum points sever in HADS questionnaire
earn points mild to sever in THI questionnaire
complete the consent form to participate in the rehabilitation in the program</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>unwillingness to cooperate in each stage of the research
no infection of neurologic legion epilepsy convulsions and no evidence of cardiovascular disease
no taking sedatives</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H93.1</hc_code>
      <hc_code>H90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tinnitus</hc_keyword>
      <hc_keyword>Conductive and sensorineural hearing loss</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: Group A- customize sound therapy will be provided together with LTA transcranial direct current stimulation (tDCS) for 20 min  , the current intensity of 2 mA will be applied 6 sessions (3 sessions per week )</i_keyword>
      <i_keyword>Intervention group: Intervention group: Group A- customize sound therapy will be provided together with DLPFC  transcranial direct current stimulation (tDCS) for 20 min  , the current intensity of 2 mA will be applied 6 sessions (3 sessions per week )</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quick-speech in noise test score. Timepoint: before the intervention- after the intervention- 1 and 3 months after the end of the intervention. Method of measurement: the percentage of correctly expressed target words - the amount of SNR loss based on the calculation formula.</prim_outcome>
      <prim_outcome>Dichotic digit test. Timepoint: before the intervention- after the intervention- 1 and 3 months after the end of the intervention. Method of measurement: according to percentage of correct answers.</prim_outcome>
      <prim_outcome>Pitch patern test. Timepoint: before the intervention- after the intervention- 1 and 3 months after the end of the intervention. Method of measurement: according to percentage of correct answers.</prim_outcome>
      <prim_outcome>Sustained attention score in the test of everyday attention (TEA-elevator counting). Timepoint: before the intervention- after the intervention- 1 and 3 months after the end of the intervention. Method of measurement: according to percentage of correct answers.</prim_outcome>
      <prim_outcome>Selective attention score  in the test of everyday attention (TEA-elevator counting with distraction ). Timepoint: before the intervention- after the intervention- 1 and 3 months after the end of the intervention. Method of measurement: according to percentage of correct answers.</prim_outcome>
      <prim_outcome>N-back test. Timepoint: before the intervention- after the intervention- 1 and 3 months after the end of the intervention. Method of measurement: according to percentage of correct answers.</prim_outcome>
      <prim_outcome>Componence of electroencephalography (EEG). Timepoint: before the intervention- after the intervention. Method of measurement: with EEGlab software.</prim_outcome>
      <prim_outcome>The score of Tinnitus Handicap Inventory (THI)  questionnaire. Timepoint: before the intervention- after the intervention- 1 and 3 months after the end of the intervention. Method of measurement: Score obtained out of 100.</prim_outcome>
      <prim_outcome>Visual Analog Score (VAS) of tinnitus. Timepoint: before the intervention- after the intervention- 1 and 3 months after the end of the intervention. Method of measurement: Score obtained out of 10.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-22</approval_date>
        <contact_name>Ethics committee of Social welfare and rehabilitation sciences</contact_name>
        <contact_address>Kodakyar ave., Daneshjo Blvd., Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
