<?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>IRCT20160131026279N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-07</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Rehabilitation and tDCS in geriatric speech perception</public_title>
      <acronym></acronym>
      <scientific_title>The  Effects  of  Dynamic Spatial  Hearing  Rehabilitation  Combined with Transcranial Electrical Stimulation on  Speech  Perception in Noise in  Elderly Men with Normal Hearing</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37952</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random assign to four equal groups with a Quadruple random blocks method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Auditory processing disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: receiving dynamic spatial hearing rehabilitation in twelve weeks (two sessions weekly, one hour each) at the center and on a daily basis at home. Intervention 2: Intervention group 2: receiving dynamic spatial hearing rehabilitation and tDCS. Dynamic spatial hearing rehabilitation in twelve weeks (two sessions weekly, one hour each) at the center and on a daily basis at home. For tDSC, the direct current which increases from a 0.5 mA intensity gradually to 2 mA (9 v), is presenting by a pair of carbon-rubber electrodes with a diameter of 21 mm and an area of 3.5 cm² dissolved in salt water, anode/right-cathod/left on the superior temporal gyrus area including planum temporale and auditory cortex (T7 and T8 regions according to the electrodes method 10-20) in three months (In the first two weeks, four sessions a week and then a weekly session), and each session will be presented 20 minutes. Intervention 3: Control group: no intervention. Intervention 4: Sham group: not receiving spatial hearing rehabilitation and is placed in the tDCS sessions of the electrode, but no electrical stimulation is applied.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mansoureh Adel Ghahraman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 4364</telephone>
        <email>madel@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansoureh Adel Ghahraman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 4364</telephone>
        <email>madel@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly men aged between 60-75 years .
The average thresholds of frequencies of 500, 1000, 2000 Hz are less than or equal to25 dB HL  in both ears, and the thresholds of each of the higher frequencies alone are less  than or equal to 40 dB HL (31) and the auditory symmetry in both ears (mean difference of threshold About dB 5 HL).
Normal middle ear: Type A Tympanogram  and Static Compailance between 0.3 and 1.6
Right handedness (based on Edinburgh Handedness Inventory)
Farsi language and Monolingual
Lack of cognitive problems (obtaining a minimum score of 21 out of 30 Mini–Mental State Examination  (MMSE)
having problem of speech perception in noisy environments based on the participant’s statement
No pacemaker due to interference with electrical stimulation
Lack of norologic disease.
Lack of uncontrolled high blood pressure or diabetes</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Normal results of all evaluations and tests used in this study before any intervention
Reluctant to continue cooperation in research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: receiving dynamic spatial hearing rehabilitation in twelve weeks (two sessions weekly, one hour each) at the center and on a daily basis at home</i_keyword>
      <i_keyword>Intervention group 2: receiving dynamic spatial hearing rehabilitation and tDCS. Dynamic spatial hearing rehabilitation in twelve weeks (two sessions weekly, one hour each) at the center and on a daily basis at home. For tDSC, the direct current which increases from a 0.5 mA intensity gradually to 2 mA (9 v), is presenting by a pair of carbon-rubber electrodes with a diameter of 21 mm and an area of 3.5 cm² dissolved in salt water, anode/right-cathod/left on the superior temporal gyrus area including planum temporale and auditory cortex (T7 and T8 regions according to the electrodes method 10-20) in three months (In the first two weeks, four sessions a week and then a weekly session), and each session will be presented 20 minutes.</i_keyword>
      <i_keyword>Control group: no intervention</i_keyword>
      <i_keyword>Sham group: not receiving spatial hearing rehabilitation and is placed in the tDCS sessions of the electrode, but no electrical stimulation is applied.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Signal to noise ratio  loss index (SNR Loss). Timepoint: Before, immediately after completing intervention, and one month after the completion of intervention. Method of measurement: Quick Speech in Noise (QSIN) Test.</prim_outcome>
      <prim_outcome>Spatial Release from Masking index. Timepoint: Before, immediately after completing intervention, and one month after the completion of intervention. Method of measurement: Binaural Masking Level Difference Test (BMLD).</prim_outcome>
      <prim_outcome>The total and subscales score of the SSQ questionnaire. Timepoint: Before, immediately after completing intervention, and one month after the completion of intervention. Method of measurement: Persian version of speech, spatial and qualities of hearing scale (SSQ).</prim_outcome>
      <prim_outcome>P1, N1, P2 latencies. Timepoint: Before, immediately after completing intervention, and one month after the completion of intervention. Method of measurement: Recording auditory late latency responses (LLR).</prim_outcome>
      <prim_outcome>N1-P2 amplitude. Timepoint: Before, immediately after completing intervention, and one month after the completion of intervention. Method of measurement: Recording auditory late latency responses (LLR).</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>2018-04-15</approval_date>
        <contact_name>School of Nursing and Midwifery &amp; Rehabilitation - Tehran University of Medical Sciences</contact_name>
        <contact_address>Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
