<?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>IRCT2017012832249N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-10</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of positive airway pressure (PAP) therapy on the components of metabolic syndrome in obstructive sleep apnea (OSA)</public_title>
      <acronym></acronym>
      <scientific_title>Positive airway pressure (PAP) therapy and its impact on the components of metabolic syndrome in obstructive sleep apnea (OSA) patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25168</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obstructive Sleep Apnea.</hc_freetext>
      <i_freetext>PAP therapy.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Mehraban</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baharloo Hospital, Behdari St., Rahahan Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5567 7333</telephone>
        <email>dr_m_mehraban@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Banafsheh Alemohammad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baharloo Hospital, Behdari St., Rahahan Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5567 7333</telephone>
        <email>alemohammadz@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria consist of adult patients with OSA and clinical indication for PAP therapy. Exclusion criteria consist of pregnancy, cardiopulmonary disorder, upper airway cancer or surgery, change or new administration of drug for hyperlipidemia, hypertension and diabetes mellitus.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>A disorder characterized by cessation of breathing for short periods during sleep</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>PAP therapy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: Sphygomanometer.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: Direct Enzymatic Colorimetric Method.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: glucose oxidase assay.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: lipase peroxidase colorometric.</prim_outcome>
      <prim_outcome>Abdominal Circumference. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: Metre.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: scale.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: scale and stadiometer.</sec_outcome>
      <sec_outcome>C reactive protein. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: quantitative latex immunoturbidimetric assay.</sec_outcome>
      <sec_outcome>Erythrocyte sedimentation rate. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: the Westergren method (therma).</sec_outcome>
      <sec_outcome>Alkaline phosphatase. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: nitrophenyl phosphate kinetic.</sec_outcome>
      <sec_outcome>Complete blood count. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: cell counter.</sec_outcome>
      <sec_outcome>Hemoglobin A1c. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: High Performance Liquid Chromatography.</sec_outcome>
      <sec_outcome>Alanine amino transferase. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: NADH Kinetic UV.</sec_outcome>
      <sec_outcome>Aspartate amino tranferase. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: NADH Kinetic UV.</sec_outcome>
      <sec_outcome>Uric acid. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: enzymatic colorimetric.</sec_outcome>
      <sec_outcome>Cholesterol. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: cholestrol oxidase peroxidase colorimetric.</sec_outcome>
      <sec_outcome>25 hydroxy vitamin D3. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: High Performance Liquid Chromatography.</sec_outcome>
      <sec_outcome>Creatinine. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: jaffe kinetic colorimetric.</sec_outcome>
      <sec_outcome>Blood urea nitrogen. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: Urease GLDH Kinetic.</sec_outcome>
      <sec_outcome>Low density lipoprotein. Timepoint: before treatment and 3 months following beginning of the treatment. Method of measurement: Direct Enzymatic colorimetric.</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>Vice chancellor for research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-28</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
