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/NCT05967754</url>
    </required_header>
    <id_info>
      <org_study_id>24/327</org_study_id>
      <nct_id>NCT05967754</nct_id>
    </id_info>
    <brief_title>Correlation Between Serum Uric Acid and Pulmonary Hypertension in Obstructive Sleep Apnea Syndrome</brief_title>
    <official_title>Correlation Between Serum Uric Acid and Pulmonary Arterial Hypertension Based on Echo Probability in Patients With Obstructive Sleep Apnea Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aimed to correlate serum uric acid levels and PAH in OSAHS patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Obstructive sleep apnea-hypopnea syndrome is the most common form of SRBDs. Recurrent&#xD;
        hypoxia, that accompanies OSAHS increases the degradation of ATP, which in turn increase uric&#xD;
        acid concentration that can be used as a biomarker of tissue hypoxia in OSAHS. There is still&#xD;
        debate about whether OSAHS is an independent contributor to pulmonary arterial hypertension.&#xD;
  &#xD;
        AIM OF THE WORK This study aimed to correlate serum uric acid levels and PAH in OSAHS&#xD;
        patients. Methods We enrolled 100 patients diagnosed with OSAHS using polysomnography.&#xD;
        Patients were divided into three severity groups: mild OSA (5 ≤ AHI &lt; 15), moderate OSA (15 ≤&#xD;
        AHI &lt; 30), and severe (30 ≤ AHI &lt; 60). Serum uric acid was measured the morning after&#xD;
        polysomnography. All patients underwent standard echocardiograms, and Pulmonary artery&#xD;
        systolic pressure calculation was done.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2018</start_date>
    <completion_date type="Actual">December 1, 2020</completion_date>
    <primary_completion_date type="Actual">October 1, 2020</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients.</measure>
      <time_frame>one Year</time_frame>
      <description>This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">100</enrollment>
    <condition>Obstructive Sleep Apnea</condition>
    <arm_group>
      <arm_group_label>Patients with Obstructive sleep Apnea</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients with Obstructive sleep Apnea</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>polysomnography</intervention_name>
      <description>polysomnography and serum uric acid measurement</description>
      <arm_group_label>Patients with Obstructive sleep Apnea</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of OSAHS by overnight polysomnography (AHI ≥ 5/ hr)&#xD;
  &#xD;
            -  ≥18 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other sleep disorders as narcolepsy or hypersomnia were excluded as well as Patients&#xD;
               with neuropsychiatric disorders.&#xD;
  &#xD;
            -  Hemodynamically unstable patients&#xD;
  &#xD;
            -  Patients with other chronic respiratory or cardiac diseases&#xD;
  &#xD;
            -  Patients with other known causes of pulmonary hypertension&#xD;
  &#xD;
            -  Patients with any disease or on medication that could alter excretion or urinary&#xD;
               metabolism of uric acid such as Excessive uric acid production&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>rania A SEWIED, doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>alex</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Rania Ahmad Sweed</name>
        <address>
          <city>Alexandria</city>
          <zip>000000</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Rania Ahmad Sweed</investigator_full_name>
      <investigator_title>clinical professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Apnea</mesh_term>
      <mesh_term>Sleep Apnea Syndromes</mesh_term>
      <mesh_term>Sleep Apnea, Obstructive</mesh_term>
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05967754
  org study id: 24/327
  nct id: NCT05967754
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to correlate serum uric acid levels and PAH in OSAHS patients.
  Obstructive sleep apnea-hypopnea syndrome is the most common form of SRBDs. Recurrent
        hypoxia, that accompanies OSAHS increases the degradation of ATP, which in turn increase uric
        acid concentration that can be used as a biomarker of tissue hypoxia in OSAHS. There is still
        debate about whether OSAHS is an independent contributor to pulmonary arterial hypertension.
  
        AIM OF THE WORK This study aimed to correlate serum uric acid levels and PAH in OSAHS
        patients. Methods We enrolled 100 patients diagnosed with OSAHS using polysomnography.
        Patients were divided into three severity groups: mild OSA (5 ≤ AHI < 15), moderate OSA (15 ≤
        AHI < 30), and severe (30 ≤ AHI < 60). Serum uric acid was measured the morning after
        polysomnography. All patients underwent standard echocardiograms, and Pulmonary artery
        systolic pressure calculation was done.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients.
  time frame: one Year
  description: This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients.
  arm group label: Patients with Obstructive sleep Apnea
  arm group type: Other
  description: Patients with Obstructive sleep Apnea
  intervention type: Diagnostic Test
  intervention name: polysomnography
  description: polysomnography and serum uric acid measurement
  arm group label: Patients with Obstructive sleep Apnea
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: rania A SEWIED, doctor
  role: Principal Investigator
  affiliation: alex
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Alexandria University
  investigator full name: Rania Ahmad Sweed
  investigator title: clinical professor
  mesh term: Apnea
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Hypertension
  sharing ipd: No