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/NCT06027372</url>
    </required_header>
    <id_info>
      <org_study_id>2020-04-016BC</org_study_id>
      <nct_id>NCT06027372</nct_id>
    </id_info>
    <brief_title>Heart Rate Variability and Nocturnal Blood Oxygen Saturation in Patients With Idiopathic Pulmonary Fibrosis</brief_title>
    <official_title>Differences in Heart Rate Variability and Nocturnal Blood Oxygen Saturation of Patients With Idiopathic Pulmonary Fibrosis Between at Baseline and During Acute Exacerbation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Veterans General Hospital, Taiwan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taipei Veterans General Hospital, Taiwan</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>
        The goal of this observational study is to compare the overnight heart rate variability (HRV)&#xD;
        and nocturnal oxygen saturation (SpO2) in patients with idiopathic pulmonary fibrosis (IPF).&#xD;
        The main questions it aims to answer are: (1). if there are correlations between pulmonary&#xD;
        function test and HRV and overnight SpO2; (2). if HRV and SpO2 can predict the occurrence of&#xD;
        acute exacerbation in patients with IPF. Participants will be asked to examine pulmonary&#xD;
        function test (including lung volumes and six-minute walk test) and wear pulse oxygenation&#xD;
        recorder and &quot;LARGAN&quot; ECG Holter&quot; (&quot;LARGAN HEALTH TECHNOLOGY&quot; Sleep Apnea And Sleep Quality&#xD;
        Examination System) during sleep.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 21, 2020</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 27, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The correlations between measures of pulmonary function test and heart rate variability</measure>
      <time_frame>1 day test duration</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Idiopathic Pulmonary Fibrosis</condition>
    <arm_group>
      <arm_group_label>IPF patients with acute exacerbation during test period</arm_group_label>
      <description>IPF patients completing pulmonary function, overnight SpO2 monitor and &quot;LARGAN&quot; ECG Holter reqire hospitalization during test period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IPF patients without acute exacerbation during test period</arm_group_label>
      <description>IPF patients completing pulmonary function, overnight SpO2 monitor and &quot;LARGAN&quot; ECG Holter remain stable during test period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>&quot;LARGAN&quot; ECG Holter</intervention_name>
      <description>wear &quot;LARGAN&quot; ECG Holter during sleep once after completion of pulmonary function test</description>
      <arm_group_label>IPF patients with acute exacerbation during test period</arm_group_label>
      <arm_group_label>IPF patients without acute exacerbation during test period</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          individuals meet the diagnosis of idiopathic pulmonary fibrosis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  individuals meet the diagnosis of idiopathic pulmonary fibrosis&#xD;
  &#xD;
            -  individuals agree to participate this study and sign the informed consent&#xD;
  &#xD;
            -  individuals have cognitive and behavioral abilities&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age less than 50 years old&#xD;
  &#xD;
            -  individuals refuse to participate this study and sign the informed consent&#xD;
  &#xD;
            -  individuals of unclear consciousness&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Diahn-Warng Perng, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fang-Chi Lin, PhD</last_name>
      <phone>+886-937-021-807</phone>
      <email>fclin3@vghtpe.gov.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Taipei Veterans General Hospital</name>
        <address>
          <city>Taipei</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fang-Chi Lin</last_name>
        <phone>+886-937-021-807</phone>
        <email>fclin3@vghtpe.gov.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Fibrosis</mesh_term>
      <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>under reasonable request</ipd_description>
    </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/NCT06027372
  org study id: 2020-04-016BC
  nct id: NCT06027372
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to compare the overnight heart rate variability (HRV)
        and nocturnal oxygen saturation (SpO2) in patients with idiopathic pulmonary fibrosis (IPF).
        The main questions it aims to answer are: (1). if there are correlations between pulmonary
        function test and HRV and overnight SpO2; (2). if HRV and SpO2 can predict the occurrence of
        acute exacerbation in patients with IPF. Participants will be asked to examine pulmonary
        function test (including lung volumes and six-minute walk test) and wear pulse oxygenation
        recorder and "LARGAN" ECG Holter" ("LARGAN HEALTH TECHNOLOGY" Sleep Apnea And Sleep Quality
        Examination System) during sleep.
  observational model: Case-Only
  time perspective: Prospective
  measure: The correlations between measures of pulmonary function test and heart rate variability
  time frame: 1 day test duration
  arm group label: IPF patients with acute exacerbation during test period
  description: IPF patients completing pulmonary function, overnight SpO2 monitor and "LARGAN" ECG Holter reqire hospitalization during test period.
  arm group label: IPF patients without acute exacerbation during test period
  description: IPF patients completing pulmonary function, overnight SpO2 monitor and "LARGAN" ECG Holter remain stable during test period.
  intervention type: Device
  intervention name: "LARGAN" ECG Holter
  description: wear "LARGAN" ECG Holter during sleep once after completion of pulmonary function test
  arm group label: IPF patients with acute exacerbation during test period
  arm group label: IPF patients without acute exacerbation during test period
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Diahn-Warng Perng, PhD
  role: Study Director
  affiliation: Taipei Veterans General Hospital, Taiwan
  last name: Fang-Chi Lin, PhD
  phone: +886-937-021-807
  email: fclin3@vghtpe.gov.tw
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Pulmonary Fibrosis
  mesh term: Idiopathic Pulmonary Fibrosis
  mesh term: Fibrosis
  sharing ipd: Undecided
  ipd description: under reasonable request