<?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>IRCT20161206031257N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of word in noise training on speech perception in the noise</public_title>
      <acronym></acronym>
      <scientific_title>The effect of word in noise training on speech perception in the noise of children with unilateral hearing loss 8 to 12 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>13</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62689</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Unilateral hearing loss.</hc_freetext>
      <i_freetext>Intervention group: After baseline assessments, the child enters the rehabilitation treatment phase. To perform rehabilitation exercises in the presence of noise, one of the ten lists without noise is first presented to the children so that they become familiar with the style of words and how to respond. Then the main exercise begins. The simplest mode of practice is when the signal-to-noise ratio is the ratio of speech to noise consisting of eight speakers. In practice, the speech intensity is fixed at 62dBHL and the initial noise level is 50dBHL, ie SNR = + 12. It should be noted that the best way to do the noise exercise is to align the ear, but if the first step is difficult for the child, the noise can be sent to the other ear and after the child progresses, the noise will be presented in the same ear. At each stage, the child's mistakes must be recorded. Errors include mispronouncing a word, omitting one of the letters, or not saying the whole word. If the child makes less than four to six errors out of ten words in the eight lists, the signal-to-noise ratio is reduced to 2 dB. Exercises are repeated every day for 45 minutes (average about 8 lists) twice a week. Completion of the exercise is the stage when the child can reach the final stage, which is the SNR 0 dB. Or it is better to say that if the child has a total of four to six errors in this ratio and ratios close to zero (such as 2 and 4 decibels), it indicates the child's proper performance in these exercises. If an error occurs and there are more than four errors in each list, it is necessary to repeat other lists at the same SNR level or improve this ratio. So below is the answer to the question, "What should we do if they mispronounce the correct word?" Hold the exercise and tell the child to be careful, listen again, what word do you hear? And we say one of the letters to the child. For example, if the first letter was "n" and not "m", we keep practicing and improve the signal-to-noise ratio..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data and documents of this study will be published via thesis and a journal paper

When:
Access date: form 2022

To whom:
Researchers

Conditions:
Meta-analysis

Where to obtain:
Contact the project manager

How to obtain:
Corresponding via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nematollah Rouhbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7764 4939</telephone>
        <email>rohbakhn@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nematollah Rouhbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7764 4939</telephone>
        <email>rohbakhn@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>8 to 12-year-old- Unilateral hearing loss, the pure tone average threshold in one ear is greater than or equal to 55 dB (moderate hearing loss) and less than 15 dB in the other ear
Do not use hearing aids
No dysfunction in the middle ear
Do not have any auditory and music rehabilitation before this study</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Experience using hearing aids
Receive any rehabilitation services
History of receiving ototoxic drugs
History of exposure to noise harmful to the auditory system (for example, exposure to noise greater than 85 dBA)
The existence of any neurological disorder that is proven in the initial case history using a questionnaire.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H90.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sensorineural hearing loss, unilateral with unrestricted hearing on the contralateral side</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After baseline assessments, the child enters the rehabilitation treatment phase. To perform rehabilitation exercises in the presence of noise, one of the ten lists without noise is first presented to the children so that they become familiar with the style of words and how to respond. Then the main exercise begins. The simplest mode of practice is when the signal-to-noise ratio is the ratio of speech to noise consisting of eight speakers. In practice, the speech intensity is fixed at 62dBHL and the initial noise level is 50dBHL, ie SNR = + 12. It should be noted that the best way to do the noise exercise is to align the ear, but if the first step is difficult for the child, the noise can be sent to the other ear and after the child progresses, the noise will be presented in the same ear. At each stage, the child's mistakes must be recorded. Errors include mispronouncing a word, omitting one of the letters, or not saying the whole word. If the child makes less than four to six errors out of ten words in the eight lists, the signal-to-noise ratio is reduced to 2 dB. Exercises are repeated every day for 45 minutes (average about 8 lists) twice a week. Completion of the exercise is the stage when the child can reach the final stage, which is the SNR 0 dB. Or it is better to say that if the child has a total of four to six errors in this ratio and ratios close to zero (such as 2 and 4 decibels), it indicates the child's proper performance in these exercises. If an error occurs and there are more than four errors in each list, it is necessary to repeat other lists at the same SNR level or improve this ratio. So below is the answer to the question, "What should we do if they mispronounce the correct word?" Hold the exercise and tell the child to be careful, listen again, what word do you hear? And we say one of the letters to the child. For example, if the first letter was "n" and not "m", we keep practicing and improve the signal-to-noise ratio.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amplitude of Cortical Auditory Evoked Potentials. Timepoint: Before and after auditory rehabilitation. Method of measurement: WIN and CAEPs.</prim_outcome>
      <prim_outcome>Latency of  Cortical Auditory Evoked Potentials. Timepoint: Before and after auditory rehabilitation. Method of measurement: WIN and CAEPs.</prim_outcome>
      <prim_outcome>50% SNR in WIN test. Timepoint: Before and after the intervention. Method of measurement: Calculate it through formulas.</prim_outcome>
      <prim_outcome>Moderate hearing loss. Timepoint: Before and after the intervention. Method of measurement: Audiometric data.</prim_outcome>
      <prim_outcome>Severe hearing loss. Timepoint: Before and after the intervention. Method of measurement: Audiometric data.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-27</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery, and School of Rehabilitation, Tehran </contact_name>
        <contact_address>Enghelab Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
