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/NCT06012526</url>
    </required_header>
    <id_info>
      <org_study_id>BeniSuefU MMSS</org_study_id>
      <nct_id>NCT06012526</nct_id>
    </id_info>
    <brief_title>The Study of Sleep Disordered Breathing in Patients With Interstitial Lung Diseases</brief_title>
    <official_title>Study of the Prevalence and Predictive Factors of Sleep Disordered Breathing in Patients With Interstitial Lung Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef University</source>
    <oversight_info>
      <has_dmc>No</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 was a cross-sectional observational study to evaluate the prevalence and predictive&#xD;
        factors of SDB in ILD and to analyze the relationship between polysomnography (PSG) findings,&#xD;
        pulmonary function, disease severity, parenchymal involvement, and sleep questionnaires ESS&#xD;
        and SBQ. This study included 69 patients who were diagnosed with diffuse parenchymal lung&#xD;
        diseases by high-resolution computed tomography (HRCT) chest. All patients were subjected to&#xD;
        clinical examination, HRCT, spirometry, full-night polysomnography, and echocardiography.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 25, 2020</start_date>
    <completion_date type="Actual">July 24, 2022</completion_date>
    <primary_completion_date type="Actual">April 20, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Measurements of apnea hypopnea index</measure>
      <time_frame>1and half years</time_frame>
      <description>Polysomnography can measure apnea hypopnea index of all patients to detect sleep disordered breathing</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">69</enrollment>
    <condition>Obstructive Sleep Apnea-hypopnea</condition>
    <arm_group>
      <arm_group_label>OSA group</arm_group_label>
      <description>The group of patients who had sleep disordered breathing</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No OSA group</arm_group_label>
      <description>The group of patients who had not sleep disordered breathing</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Polysomnography</intervention_name>
      <description>Polysomnography is done for patients to find any sleep disordered breathing</description>
      <arm_group_label>No OSA group</arm_group_label>
      <arm_group_label>OSA group</arm_group_label>
      <other_name>Sleep study</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          69 patients with interstitial lung diseases of both sexs and older than 18 years&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Both sexes of clinically stable ILD patients older than 18 who met the ATS/ERS&#xD;
               criteria for an ILD diagnosis were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have any anatomic upper airway obstructions such as significant nasal&#xD;
               septal deviation, nasal polyps, conchae hypertrophy or tonsillar hypertrophy.&#xD;
  &#xD;
            -  Patients with neurological diseases or severe psychiatric disorders.&#xD;
  &#xD;
            -  Patients who have history of administration of any drug that has a major effect on&#xD;
               sleep e.g. benzodiazepine, narcotic drugs ….etc.&#xD;
  &#xD;
            -  Patients with any chronic pulmonary disease except ILD.&#xD;
  &#xD;
            -  Total sleep time less than 4 hours on PSG.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nabila Ebrahim Laz, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Head of chest department in BeniSuef university</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Beni suef university</name>
        <address>
          <city>Banī Suwayf</city>
          <state>Beni Suef</state>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>Mona Mahmoud Srour Soliman</investigator_full_name>
      <investigator_title>Assistant lecturer</investigator_title>
    </responsible_party>
    <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>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Interstitial</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>E mail address only can be shared</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    </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/NCT06012526
  org study id: BeniSuefU MMSS
  nct id: NCT06012526
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This was a cross-sectional observational study to evaluate the prevalence and predictive
        factors of SDB in ILD and to analyze the relationship between polysomnography (PSG) findings,
        pulmonary function, disease severity, parenchymal involvement, and sleep questionnaires ESS
        and SBQ. This study included 69 patients who were diagnosed with diffuse parenchymal lung
        diseases by high-resolution computed tomography (HRCT) chest. All patients were subjected to
        clinical examination, HRCT, spirometry, full-night polysomnography, and echocardiography.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Measurements of apnea hypopnea index
  time frame: 1and half years
  description: Polysomnography can measure apnea hypopnea index of all patients to detect sleep disordered breathing
  arm group label: OSA group
  description: The group of patients who had sleep disordered breathing
  arm group label: No OSA group
  description: The group of patients who had not sleep disordered breathing
  intervention type: Diagnostic Test
  intervention name: Polysomnography
  description: Polysomnography is done for patients to find any sleep disordered breathing
  arm group label: No OSA group
  arm group label: OSA group
  other name: Sleep study
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Nabila Ebrahim Laz, Professor
  role: Study Chair
  affiliation: Head of chest department in BeniSuef university
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Mona Mahmoud Srour Soliman
  investigator title: Assistant lecturer
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial
  sharing ipd: Yes
  ipd description: E mail address only can be shared
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)