<?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>IRCT20190118042404N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-25</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effects of spatial auditory training on speech in noise perception in elderly</public_title>
      <acronym></acronym>
      <scientific_title>The effects of “  auditory spatial training” on informational masking release with persian version of coordinate response measure(CRM) in  elderly normal hearing listeners</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36954</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>central auditory processing disorder and speech in noise perception problem.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The people with even numbers will participate in this group. Rehabilitation sessions will be divided into some main categories: sessions with nonmeaningful competing signals such as white noise and sessions with meaningful distractive signals such as babble noise and some sentences. In all of the spatial training sessions the target signal will present from the 0 azimuth degree and the competing maskers will present from + and - 90 azimuth degree. We will use the Persian version of Quick SIN as a target signals. Every session will start from the signal to noise ratio which patient will respond correctly to less than 50 percent of sentences and will continue until 30 minutes. Training sessions will continue for 6 weeks and every week patient will participated in two sessions. Intervention 2: Control group: The persons with odd numbers will be in the control group. These people must not recieve any rehabilitative programs during this study. All of the particapated persons of our study are suffering from speech in noise perception, so we will guarantee that if our designed spatial traing has a significant value on the speech in noise perception we will administrate that to all of the control group persons.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Audiology Department, Faculty of Rehabilitative, Shah Nazari Ave, Mirdamad Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15875-4391</zip>
        <telephone>+98 21 2222 8951</telephone>
        <email>amiri.ma@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnoush Jaroolahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Audiology Department, Faculty of Rehabilitative, Shah Nazari Ave, Mirdadmad Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15875-4391</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>jarollahi.f@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All of 60 to 75 year old people who are suffering from speech in noise perception</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Normal hearing thresholds in 250 to 4000 Hz
No cognition impairment according to Mini mental state examination(MMSE).
High school diploma degree and upper
The age between 60 to 75 years old
Right handedness
Be Persian
Speech perception in noise difficulty
Normal middle ear function</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H90.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified 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: The people with even numbers will participate in this group. Rehabilitation sessions will be divided into some main categories: sessions with nonmeaningful competing signals such as white noise and sessions with meaningful distractive signals such as babble noise and some sentences. In all of the spatial training sessions the target signal will present from the 0 azimuth degree and the competing maskers will present from + and - 90 azimuth degree. We will use the Persian version of Quick SIN as a target signals. Every session will start from the signal to noise ratio which patient will respond correctly to less than 50 percent of sentences and will continue until 30 minutes. Training sessions will continue for 6 weeks and every week patient will participated in two sessions.</i_keyword>
      <i_keyword>Control group: The persons with odd numbers will be in the control group. These people must not recieve any rehabilitative programs during this study. All of the particapated persons of our study are suffering from speech in noise perception, so we will guarantee that if our designed spatial traing has a significant value on the speech in noise perception we will administrate that to all of the control group persons.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Informational masking. Timepoint: Sentence correct recognition score with Persian version of Coordinate Response Measure(CRM) in three times: before the training, immediately and 1 month after that. Method of measurement: Informational masking test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Speech, Spatial and Qualities of Hearing Scale(SSQ) score. Timepoint: In three times: before the training and immediately and 1 month after that. Method of measurement: Measure a listener's self-reported ability to hear in a variety of everyday situations according to SSQ sub tests: speech perception, spatial hearing and quality of hearing according to a 10 degree scale.</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>2018-08-26</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Near Milad Tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
