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/NCT05982652</url>
    </required_header>
    <id_info>
      <org_study_id>05-2021-293</org_study_id>
      <nct_id>NCT05982652</nct_id>
    </id_info>
    <brief_title>Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury</brief_title>
    <official_title>Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pusan National University Yangsan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pusan National University Yangsan 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>
        In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic&#xD;
        and asymptomatic groups and measured HRV during resting and tilt up tests to compare their&#xD;
        cardiovascular autonomic functions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In study protocol and the subjects were asked to lie down quietly for 5 minutes, closing&#xD;
        their eyes and avoiding talking, moving hand, legs and body, and coughing during the test.&#xD;
        R-R interval and blood pressure were measured beat-to-beat using Finometer® PRO (Finapres&#xD;
        Medical Systems, Amsterdam, Netherlands) for 6 minutes each in two positions, supine and&#xD;
        60-degree angle on the tilt table.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group)</measure>
      <time_frame>at the test time (15minutes)</time_frame>
      <description>mean HR (heart rate), mean RR(RR interval), RMSSD (mean square of the successive R-R interval differences), SDNN (standard deviation of normal-to-normal interval), LF (low frequency) domain, HF(High frequency) domain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Logistic regression analysis of heart rate variability variables according to OH and presence of symptom</measure>
      <time_frame>at the test time (15minutes)</time_frame>
      <description>the investigators conducted logistic regression analysis to evaluate the significance and impact of HRV variables associated with orthostatic hypotension and its symptoms in spinal cord injury patients.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <condition>Orthostatic Hypotension</condition>
    <condition>Heart Rate Variability</condition>
    <arm_group>
      <arm_group_label>non-OH group</arm_group_label>
      <description>without orthostaric hypotension in spinal cord injuries</description>
    </arm_group>
    <arm_group>
      <arm_group_label>symptomatic OH group</arm_group_label>
      <description>Symptomatic individuals in a patient population diagnosed with orthostatic hypotension (Symptom : dizziness, visual disturbance, nausea and headache)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>asymptomatic OH group</arm_group_label>
      <description>Asymptomatic individuals in a patient population diagnosed with orthostatic hypotension</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Individuals with SCI were recruited from a single university-affiliated rehabilitation&#xD;
          hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  spinal cord injury with or without OH&#xD;
  &#xD;
            -  aged 19 or older&#xD;
  &#xD;
            -  ASIA Impairment Scale (AIS) A to D&#xD;
  &#xD;
            -  neurological level of injury above T6.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those with heart and respiratory diseases, neurological diseases other than SCI -&#xD;
               medically unstable states&#xD;
  &#xD;
            -  Those who are taking medications affecting BP that cannot be stopped&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>PARK HAERI, Master</last_name>
      <role>Study Director</role>
      <affiliation>Pusan National University Yangsan Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup</name>
        <address>
          <city>Yangsan</city>
          <state>Gyeongnam</state>
          <zip>50612</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <reference>
      <citation>Stampas A, Zhu L, Li S. Heart rate variability in spinal cord injury: Asymptomatic orthostatic hypotension is a confounding variable. Neurosci Lett. 2019 Jun 11;703:213-218. doi: 10.1016/j.neulet.2019.03.020. Epub 2019 Mar 20.</citation>
      <PMID>30904574</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>October 13, 2022</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Pusan National University Yangsan Hospital</investigator_affiliation>
      <investigator_full_name>Hae-ri Park</investigator_full_name>
      <investigator_title>doctor</investigator_title>
    </responsible_party>
    <keyword>Spinal Cord Injuries</keyword>
    <keyword>Orthostatic Hypotension</keyword>
    <keyword>Heart rate variability</keyword>
    <keyword>Autonomic nervous system</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
      <mesh_term>Hypotension, Orthostatic</mesh_term>
      <mesh_term>Hypotension</mesh_term>
      <mesh_term>Wounds and Injuries</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/NCT05982652
  org study id: 05-2021-293
  nct id: NCT05982652
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic
        and asymptomatic groups and measured HRV during resting and tilt up tests to compare their
        cardiovascular autonomic functions.
  In study protocol and the subjects were asked to lie down quietly for 5 minutes, closing
        their eyes and avoiding talking, moving hand, legs and body, and coughing during the test.
        R-R interval and blood pressure were measured beat-to-beat using Finometer® PRO (Finapres
        Medical Systems, Amsterdam, Netherlands) for 6 minutes each in two positions, supine and
        60-degree angle on the tilt table.
  observational model: Other
  time perspective: Prospective
  measure: Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group)
  time frame: at the test time (15minutes)
  description: mean HR (heart rate), mean RR(RR interval), RMSSD (mean square of the successive R-R interval differences), SDNN (standard deviation of normal-to-normal interval), LF (low frequency) domain, HF(High frequency) domain
  measure: Logistic regression analysis of heart rate variability variables according to OH and presence of symptom
  time frame: at the test time (15minutes)
  description: the investigators conducted logistic regression analysis to evaluate the significance and impact of HRV variables associated with orthostatic hypotension and its symptoms in spinal cord injury patients.
  arm group label: non-OH group
  description: without orthostaric hypotension in spinal cord injuries
  arm group label: symptomatic OH group
  description: Symptomatic individuals in a patient population diagnosed with orthostatic hypotension (Symptom : dizziness, visual disturbance, nausea and headache)
  arm group label: asymptomatic OH group
  description: Asymptomatic individuals in a patient population diagnosed with orthostatic hypotension
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: PARK HAERI, Master
  role: Study Director
  affiliation: Pusan National University Yangsan Hospital
  facility: 
  country: Korea, Republic of
  citation: Stampas A, Zhu L, Li S. Heart rate variability in spinal cord injury: Asymptomatic orthostatic hypotension is a confounding variable. Neurosci Lett. 2019 Jun 11;703:213-218. doi: 10.1016/j.neulet.2019.03.020. Epub 2019 Mar 20.
  PMID: 30904574
  responsible party type: Principal Investigator
  investigator affiliation: Pusan National University Yangsan Hospital
  investigator full name: Hae-ri Park
  investigator title: doctor
  mesh term: Spinal Cord Injuries
  mesh term: Hypotension, Orthostatic
  mesh term: Hypotension
  mesh term: Wounds and Injuries
  sharing ipd: No