<?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>IRCT20220206053952N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-11</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of audio-visual integration in unilateral hearing loss</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of audio-visual integration and recalibration of auditory space in unilateral hearing loss pre and post auditory localization training using ventriloquism effect</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62427</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Poor Auditory Localization( Central ).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 (People with   unilateral chronic  hearing loss)     Each session is called a "learning unit". Each learning unit consists of 4 sections. In the first part, for ease of localization, the wide-band stimulus has a delay of 1000 milliseconds. On the other hand, four azimuths of 0, 90, 180 and 270 degrees are selected at this stage and the person under training is also told that the sound will be presented in one of these directions. This reduces the difficulty of locating and increases the patient's confidence to continue working. 5 stimuli will be provided from each speaker and the response will be recorded using the GUI. At this stage, the response of the patient is considered to be reinforced in such a way that, if it is correct, a green light on the response recorder will be turned on and feedback will be given. If the answer is wrong, a red light will come on first and then the correct answer will appear on the screen so that the patient can accurately identify the new symptoms. In the following, other azimuth will be presented diagonally. First Azimuth 30, 120, 210 and 300 degrees and next Azimuth 60, 150, 240 and 330 degrees in the mentioned style, the stimuli are presented and the answer related to each angle is recorded in the GUI, thus all 12 speakers Provide the stimulus and the person's response is recorded in 360 degrees.In the second part, all the previous steps are repeated using a stimulus with a delay of 300 milliseconds. In this new exercise, the positioning task becomes more difficult due to the reduction of the stimulus delay.At this stage, several corrective mechanisms have been considered to improve patients' performance. These mechanisms include the following:              1- Following the correct answer, the green light turns on for confirmation.2- After the wrong answer, the correct location of the speaker is displayed to increase the patient's accuracy 3- The angles that are answered incorrectly are identified and repeated in the next session  4- In angles where the wrong answer is not corrected, by limiting the patient's choices, it helps to increase his accuracy.In the third part, the task of localization becomes more difficult. In this way, the stimuli are presented randomly from the speakers and the listener has no background of the stimulus location and is no longer aware of the possible position of the sound source. In this section, the stimulus duration is 1000 milliseconds. Providing feedback and recording responses is the same as the previous step.In the fourth part, the details of the third part are applied, with the difference that the stimulus delay is 300 milliseconds. This will be the most difficult task for the patient.In total, there will be two weeks for each person and 3 days each week and one learning unit per day.After completing the four sections of the rehabilitation sessions, the patients' last response is recorded as "post-rehabilitation orientation response". Intervention 2: Intervention group 2: (People with normal hearing)                                               All interventions to the intervention group 1 will be done here as well.</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 It will be Specified by the supervisor</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Geshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, Madadkaran Str., Shahnazari Ave., Madar Sqr., Mirdamad Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15459-13487</zip>
        <telephone>+98 21 2225 0541</telephone>
        <email>ageshani@tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnoush Jarollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, Madadkaran Str., Shahnazari Ave., Madar Sqr., Mirdamad Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15459-13487</zip>
        <telephone>+98 21 2225 0541</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>Inclusion criteria in the norm group:
Normal hearing thresholds (based on goodman 1965)
Normal middle ear function
Absence of external ear l anomalies
No history of ear surgery
Not taking drugs that affect the CNS such as antiepileptic drugs and ...
Norm vision
Being right-handed
No history of professional activity in music
unilateral chronic hearing loss  group:
Presence of conductive hearing loss in the right ear, with  more than 30 dB HL
Hearing loss has lasted for at least 6 months
Absence of external ear l anomalies
Absence of cerumen and foreign body in the ear canal
No history of ear surgery
Not taking drugs that affect the CNS such as antiepileptic drugs and ...
Normal vision
Being right-handed
No history of professional activity in music</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue participating in the study at any stage</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H93.25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Poor Auditory Localization( Central )</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 (People with   unilateral chronic  hearing loss)     Each session is called a "learning unit". Each learning unit consists of 4 sections. In the first part, for ease of localization, the wide-band stimulus has a delay of 1000 milliseconds. On the other hand, four azimuths of 0, 90, 180 and 270 degrees are selected at this stage and the person under training is also told that the sound will be presented in one of these directions. This reduces the difficulty of locating and increases the patient's confidence to continue working. 5 stimuli will be provided from each speaker and the response will be recorded using the GUI. At this stage, the response of the patient is considered to be reinforced in such a way that, if it is correct, a green light on the response recorder will be turned on and feedback will be given. If the answer is wrong, a red light will come on first and then the correct answer will appear on the screen so that the patient can accurately identify the new symptoms. In the following, other azimuth will be presented diagonally. First Azimuth 30, 120, 210 and 300 degrees and next Azimuth 60, 150, 240 and 330 degrees in the mentioned style, the stimuli are presented and the answer related to each angle is recorded in the GUI, thus all 12 speakers Provide the stimulus and the person's response is recorded in 360 degrees.In the second part, all the previous steps are repeated using a stimulus with a delay of 300 milliseconds. In this new exercise, the positioning task becomes more difficult due to the reduction of the stimulus delay.At this stage, several corrective mechanisms have been considered to improve patients' performance. These mechanisms include the following:              1- Following the correct answer, the green light turns on for confirmation.2- After the wrong answer, the correct location of the speaker is displayed to increase the patient's accuracy 3- The angles that are answered incorrectly are identified and repeated in the next session  4- In angles where the wrong answer is not corrected, by limiting the patient's choices, it helps to increase his accuracy.In the third part, the task of localization becomes more difficult. In this way, the stimuli are presented randomly from the speakers and the listener has no background of the stimulus location and is no longer aware of the possible position of the sound source. In this section, the stimulus duration is 1000 milliseconds. Providing feedback and recording responses is the same as the previous step.In the fourth part, the details of the third part are applied, with the difference that the stimulus delay is 300 milliseconds. This will be the most difficult task for the patient.In total, there will be two weeks for each person and 3 days each week and one learning unit per day.After completing the four sections of the rehabilitation sessions, the patients' last response is recorded as "post-rehabilitation orientation response".</i_keyword>
      <i_keyword>Intervention group 2: (People with normal hearing)                                               All interventions to the intervention group 1 will be done here as well</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Localization Improvement Ventriloquist Effect Improvement Ventriloquist After Effect Improvement. Timepoint: Before and after Intervention. Method of measurement: By Testing.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Auditory Localization with BBN Stimui in 12 Azimoth Auditory Localization with Low/ High / BBN Stimuli in 5 Azim. Timepoint: Before and after intervention. Method of measurement: By testing.</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>2022-02-19</approval_date>
        <contact_name>Research Ethics Committees of Iran University of Medical Sciences</contact_name>
        <contact_address>Audiology department, School of Rehabilitation Sciences, Iran University of Medical Sciences Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran TEHRAN Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
