xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05990010</url>
    </required_header>
    <id_info>
      <org_study_id>22/130/2020</org_study_id>
      <nct_id>NCT05990010</nct_id>
    </id_info>
    <brief_title>OSA Prevalence in Atrial Fibrillation Patients: Jordanian Study</brief_title>
    <official_title>Prevalence of Obstructive Sleep Apnea Among Atrial Fibrillation Patients: A Cross-sectional Study From Jordan</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King Abdullah University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>King Abdullah University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Current Knowledge:&#xD;
  &#xD;
        Countless studies have been conducted to study the relationship between OSA and AF, and a&#xD;
        significant association has been established between both diseases, owing to the numerous&#xD;
        shared risk factors and a wide variety of pathophysiological changes resulting from both&#xD;
        diseases being relevant to each other. Our study inspects this relationship from a&#xD;
        cardiovascular standpoint, examining the prevalence of OSA in existing AF patients, which&#xD;
        could be interpreted as AF being a risk factor for OSA development.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 2, 2020</start_date>
    <completion_date type="Actual">July 25, 2023</completion_date>
    <primary_completion_date type="Actual">July 25, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The Berlin Questionnaire survey</measure>
      <time_frame>baseline</time_frame>
      <description>Prevalence of Obstructive Sleep Apnea among Atrial Fibrillation Patients</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">545</enrollment>
    <condition>Atrial Fibrillation</condition>
    <condition>Obstructive Sleep Apnea</condition>
    <arm_group>
      <arm_group_label>Patients with AF</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients without AF</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Berlin Questionnaire</intervention_name>
      <description>The Berlin Questionnaire is a simple survey that helps doctors identify OSA risk. It looks at snoring, daytime sleepiness, obesity, and hypertension. A positive score in two or more areas indicates high risk, while one or none suggests low risk. It is an easy and effective tool to assess OSA risk, with proven validity.</description>
      <arm_group_label>Patients with AF</arm_group_label>
      <arm_group_label>Patients without AF</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who had visited King Abdullah University Hospital cardiology clinics within the&#xD;
          timeframe of (2017-2019).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 21 or above&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to give research consent&#xD;
  &#xD;
            -  Patients who were unwilling to complete the questionnaires&#xD;
  &#xD;
            -  Patients who suffer from mental illness&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>King Abdullah University Hospital cardiology clinics</name>
        <address>
          <city>Irbid</city>
          <state>Ramtha</state>
          <zip>22110</zip>
          <country>Jordan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>King Abdullah University Hospital</investigator_affiliation>
      <investigator_full_name>Rashid Ibdah</investigator_full_name>
      <investigator_title>Rashid Ibdah, MD</investigator_title>
    </responsible_party>
    <keyword>AF</keyword>
    <keyword>OSA</keyword>
    <keyword>berlin questionnaire</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Apnea Syndromes</mesh_term>
      <mesh_term>Sleep Apnea, Obstructive</mesh_term>
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05990010
  org study id: 22/130/2020
  nct id: NCT05990010
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Current Knowledge:
  
        Countless studies have been conducted to study the relationship between OSA and AF, and a
        significant association has been established between both diseases, owing to the numerous
        shared risk factors and a wide variety of pathophysiological changes resulting from both
        diseases being relevant to each other. Our study inspects this relationship from a
        cardiovascular standpoint, examining the prevalence of OSA in existing AF patients, which
        could be interpreted as AF being a risk factor for OSA development.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: The Berlin Questionnaire survey
  time frame: baseline
  description: Prevalence of Obstructive Sleep Apnea among Atrial Fibrillation Patients
  arm group label: Patients with AF
  arm group label: Patients without AF
  intervention type: Diagnostic Test
  intervention name: Berlin Questionnaire
  description: The Berlin Questionnaire is a simple survey that helps doctors identify OSA risk. It looks at snoring, daytime sleepiness, obesity, and hypertension. A positive score in two or more areas indicates high risk, while one or none suggests low risk. It is an easy and effective tool to assess OSA risk, with proven validity.
  arm group label: Patients with AF
  arm group label: Patients without AF
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Jordan
  responsible party type: Principal Investigator
  investigator affiliation: King Abdullah University Hospital
  investigator full name: Rashid Ibdah
  investigator title: Rashid Ibdah, MD
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Atrial Fibrillation
  sharing ipd: Undecided