<?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>IRCT20210220050431N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-21</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Auditory Localization training</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Auditory Localization Training on Speed Processing and Speech Perception in Elderly with Difficulty in Speech Perception-In-Noise</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54496</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method was used for random allocation. Using the website "sealed envelope.com", the statistician designed this two-group experiment of 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Blocking is usually done to balance The number of samples assigned to each of the study groups should be used. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The size of all the blocks is the same and we will have. Randomization tool also uses random allocation software (software allocation Random) that these random sequence generation software in addition to simple randomization are able to generate random sequence by blocking method. For concealment we use concealment allocation. The sample allocation ratio will be (1: 1 Allocation). Then, based on the obtained blocks, the sequence of allocation of rehabilitation exercises will be given to the patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Speech Perception difficulty in noise.</hc_freetext>
      <i_freetext>Intervention 1: Localization training sessions are held twice a week, for 45 minutes each time for 10 to 12 sessions per person. Two high- pass noise and low-pass noise stimuli with a cut-off point of 2 kHz, a delay of 250 milliseconds and a fall time of 20 milliseconds will be used.Sounds with different ITDs are provided through headphones, and the person must respond by indicating where the sound source is perceived. Stimulus will be offered  binaurally with time differences of 880, 660, 440, 220, 0, -220, -440, -880 microseconds in the intensity of 50 dBHL. Negative and positive represent the left and right ears.Each ITD is rehearsed with the person several times to be well recognizable to the individual and the individual must indicate the location of the audio source. Intervention 2: Control group: No rehabilitation will be performed for the control group, but after the completion of the project, it is suggested that if desired, the same rehabilitation period be performed for them.</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:
All potential data can be shared after de-identifying individuals.

When:
Access period starts 3 months after the results are published.

To whom:
The data of this study will be avalable to researchers working in academic and scientific institution.

Conditions:
Futur analysis of the delivered date will be possible only with the coordination of the main researcher.

Where to obtain:
Applicant can submit their application by sending an email to the lead researcher.

How to obtain:
The request is first submitted to the principal investigator. The data is then send to the applicant in coordination with other research colleagues and in determining the applicants purpose.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jafar Aghazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, first Behestan Ave, Pasdaran Aly</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946863198</zip>
        <telephone>+98 21 2277 7567</telephone>
        <email>jafar_aghazadeh@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jafar Aghazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.6, First Behestan Ave, Pasdaran Aly</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946863198</zip>
        <telephone>+98 21 2277 7567</telephone>
        <email>jafar_aghazadeh@yahho.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Hearing range better than 25 dBHL at frequencies from 250 to 4000 Hz and symmetrical hearing in both Ears (mean threshold difference about 5 dB)
Complaining and expressing difficulty in understanding speech in crowded environments
Low score (less than 7) in The Persian version of The .P-SSQ questionnaire
Signal to noise ratio Index (SNRLOSS) above 7 dB in the Persian version of the Q-SIN test
Normal status of the middle ear and normal results of the acoustic reflex and tympanometry, tympanogram type A and static compliance from 0.3 to 1.6
Earn a minimum of 25 Points in the MMSE evaluation
No neurological and autologic disorders
Lack of a history of neurological and mental disorders
Persian language
Age range 65 to 75 years</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to collaborate at any stage of research
Loss of any of the changeable input criteria</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H93.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other abnormal auditory perceptions</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Localization training sessions are held twice a week, for 45 minutes each time for 10 to 12 sessions per person. Two high- pass noise and low-pass noise stimuli with a cut-off point of 2 kHz, a delay of 250 milliseconds and a fall time of 20 milliseconds will be used.Sounds with different ITDs are provided through headphones, and the person must respond by indicating where the sound source is perceived. Stimulus will be offered  binaurally with time differences of 880, 660, 440, 220, 0, -220, -440, -880 microseconds in the intensity of 50 dBHL. Negative and positive represent the left and right ears.Each ITD is rehearsed with the person several times to be well recognizable to the individual and the individual must indicate the location of the audio source.</i_keyword>
      <i_keyword>Control group: No rehabilitation will be performed for the control group, but after the completion of the project, it is suggested that if desired, the same rehabilitation period be performed for them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time compressed speech test score. Timepoint: Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation. Method of measurement: Percentage of repetition of words heard.</prim_outcome>
      <prim_outcome>Word recognition score in noise. Timepoint: Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation. Method of measurement: Correct recognition of word.</prim_outcome>
      <prim_outcome>Consonant-Vowel in Noise Test Score. Timepoint: Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation. Method of measurement: Percentage of Correct recognition of syllables.</prim_outcome>
      <prim_outcome>Reaction time. Timepoint: Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation. Method of measurement: Using the software in milliseconds.</prim_outcome>
      <prim_outcome>Latency of N1-P2 wave. Timepoint: Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation. Method of measurement: Using the software in milliseconds.</prim_outcome>
      <prim_outcome>Amplitude of N1-P2 wave. Timepoint: Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation. Method of measurement: Using the software in microvolts.</prim_outcome>
      <prim_outcome>Interaural Time Difference. Timepoint: Before starting rehabilitation, immediately after the end of rehabilitation, one month after the end of rehabilitation. Method of measurement: Indicate the location of the audio source.</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>2020-01-14</approval_date>
        <contact_name>Ethics Committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Kodakyar Ave, Daneshjo Blvd, Evin (Velenjak) Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
