<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/NCT03243448</url>
  </required_header>
  <id_info>
    <org_study_id>KMU-DK106011</org_study_id>
    <nct_id>NCT03243448</nct_id>
  </id_info>
  <brief_title>Skin Sympathetic Nerve Activity and Sympathetic Tone</brief_title>
  <official_title>Using Skin Sympathetic Nerve Activity to Estimate Sympathetic Tone in Human</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
  <brief_summary>
    <textblock>
      There are many sympathetic hyperactivity diseases in the investigators' clinical practice.&#xD;
      However, the conventional method to measure the sympathetic nerve activity had many&#xD;
      limitations such as clinical application, data interpretation and even therapeutic&#xD;
      manipulation. Therefore the investigators would like to develop a non-invasive method to&#xD;
      record the sympathetic nerve activity in the investigators' study that can help gathering the&#xD;
      sympathetic nerve activity easily in the investigators' daily clinical situation. By the&#xD;
      determination of sympathetic nerve activity status, the health caregiver can understand the&#xD;
      disease more.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Anticipated">July 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Skin Sympathetic Nerve Activity</measure>
    <time_frame>12 hours</time_frame>
    <description>The Sympathetic Nerve Activity Recording from the skin of the subjects in the day time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ventricular arrhythmia</measure>
    <time_frame>24 to 72 hours</time_frame>
    <description>The electrocardiogram recording from the telemetry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 to 12 months</time_frame>
    <description>The mortality will be accessed by the chart review and telephone access</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>1 to 12 months</time_frame>
    <description>The morbidity will be accessed by the chart review and telephone access</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Nerve; Disorder, Sympathetic</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>The general public</arm_group_label>
    <description>people between 20-85 years old, without sympathetic hyperactivity disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sympathetic hyperactivity diseases</arm_group_label>
    <description>Sympathetic hyperactivity diseases included: hypertension, heart failure atherosclerotic diseases, arrhythmias, cardiomyopathy, pulmonary hypertension, chronic obstructive pulmonary disease, sleep apnea, pulmonary embolism, hepatitis, liver cirrhosis, hepatopulmonary syndrome, hepatorenal syndrome, renal failure, nephritis, irritable bowel syndrome.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects who are eligible to the inclusion criteria and admitted to the investigators'&#xD;
        ward, visited the investigators' outpatient clinic or health checkup center will be&#xD;
        enrolled in the investigators' study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sympathetic hyperactivity diseases included: hypertension, heart failure&#xD;
             atherosclerotic diseases, arrhythmias, cardiomyopathy, pulmonary hypertension, chronic&#xD;
             obstructive pulmonary disease, sleep apnea, pulmonary embolism, hepatitis, liver&#xD;
             cirrhosis, hepatopulmonary syndrome, hepatorenal syndrome, renal failure, nephritis,&#xD;
             irritable bowel syndrome.&#xD;
&#xD;
          -  Healthy Volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Shen MJ, Coffey AC, Straka S, Adams DE, Wagner DB, Kovacs RJ, Clark M, Shen C, Chen LS, Everett TH 4th, Lin SF, Chen PS. Simultaneous recordings of intrinsic cardiac nerve activity and skin sympathetic nerve activity from human patients during the postoperative period. Heart Rhythm. 2017 Nov;14(11):1587-1593. doi: 10.1016/j.hrthm.2017.06.030. Epub 2017 Jun 23.</citation>
    <PMID>28648667</PMID>
  </results_reference>
  <results_reference>
    <citation>Everett TH 4th, Doytchinova A, Cha YM, Chen PS. Recording sympathetic nerve activity from the skin. Trends Cardiovasc Med. 2017 Oct;27(7):463-472. doi: 10.1016/j.tcm.2017.05.003. Epub 2017 May 10.</citation>
    <PMID>28619579</PMID>
  </results_reference>
  <results_reference>
    <citation>Uradu A, Wan J, Doytchinova A, Wright KC, Lin AYT, Chen LS, Shen C, Lin SF, Everett TH 4th, Chen PS. Skin sympathetic nerve activity precedes the onset and termination of paroxysmal atrial tachycardia and fibrillation. Heart Rhythm. 2017 Jul;14(7):964-971. doi: 10.1016/j.hrthm.2017.03.030. Epub 2017 Mar 24.</citation>
    <PMID>28347833</PMID>
  </results_reference>
  <results_reference>
    <citation>Doytchinova A, Hassel JL, Yuan Y, Lin H, Yin D, Adams D, Straka S, Wright K, Smith K, Wagner D, Shen C, Salanova V, Meshberger C, Chen LS, Kincaid JC, Coffey AC, Wu G, Li Y, Kovacs RJ, Everett TH 4th, Victor R, Cha YM, Lin SF, Chen PS. Simultaneous noninvasive recording of skin sympathetic nerve activity and electrocardiogram. Heart Rhythm. 2017 Jan;14(1):25-33. doi: 10.1016/j.hrthm.2016.09.019. Epub 2016 Sep 23.</citation>
    <PMID>27670627</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03243448
org study id: KMU-DK106011
nct id: NCT03243448
lead sponsor: 
There are many sympathetic hyperactivity diseases in the investigators' clinical practice.
      However, the conventional method to measure the sympathetic nerve activity had many
      limitations such as clinical application, data interpretation and even therapeutic
      manipulation. Therefore the investigators would like to develop a non-invasive method to
      record the sympathetic nerve activity in the investigators' study that can help gathering the
      sympathetic nerve activity easily in the investigators' daily clinical situation. By the
      determination of sympathetic nerve activity status, the health caregiver can understand the
      disease more.
observational model: Case-Control
time perspective: Prospective
measure: Skin Sympathetic Nerve Activity
time frame: 12 hours
description: The Sympathetic Nerve Activity Recording from the skin of the subjects in the day time.
measure: ventricular arrhythmia
time frame: 24 to 72 hours
description: The electrocardiogram recording from the telemetry.
measure: Mortality
time frame: 1 to 12 months
description: The mortality will be accessed by the chart review and telephone access
measure: Morbidity
time frame: 1 to 12 months
description: The morbidity will be accessed by the chart review and telephone access
arm group label: The general public
description: people between 20-85 years old, without sympathetic hyperactivity disease
arm group label: Sympathetic hyperactivity diseases
description: Sympathetic hyperactivity diseases included: hypertension, heart failure atherosclerotic diseases, arrhythmias, cardiomyopathy, pulmonary hypertension, chronic obstructive pulmonary disease, sleep apnea, pulmonary embolism, hepatitis, liver cirrhosis, hepatopulmonary syndrome, hepatorenal syndrome, renal failure, nephritis, irritable bowel syndrome.
Blood sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Shen MJ, Coffey AC, Straka S, Adams DE, Wagner DB, Kovacs RJ, Clark M, Shen C, Chen LS, Everett TH 4th, Lin SF, Chen PS. Simultaneous recordings of intrinsic cardiac nerve activity and skin sympathetic nerve activity from human patients during the postoperative period. Heart Rhythm. 2017 Nov;14(11):1587-1593. doi: 10.1016/j.hrthm.2017.06.030. Epub 2017 Jun 23.
PMID: 28648667
citation: Everett TH 4th, Doytchinova A, Cha YM, Chen PS. Recording sympathetic nerve activity from the skin. Trends Cardiovasc Med. 2017 Oct;27(7):463-472. doi: 10.1016/j.tcm.2017.05.003. Epub 2017 May 10.
PMID: 28619579
citation: Uradu A, Wan J, Doytchinova A, Wright KC, Lin AYT, Chen LS, Shen C, Lin SF, Everett TH 4th, Chen PS. Skin sympathetic nerve activity precedes the onset and termination of paroxysmal atrial tachycardia and fibrillation. Heart Rhythm. 2017 Jul;14(7):964-971. doi: 10.1016/j.hrthm.2017.03.030. Epub 2017 Mar 24.
PMID: 28347833
citation: Doytchinova A, Hassel JL, Yuan Y, Lin H, Yin D, Adams D, Straka S, Wright K, Smith K, Wagner D, Shen C, Salanova V, Meshberger C, Chen LS, Kincaid JC, Coffey AC, Wu G, Li Y, Kovacs RJ, Everett TH 4th, Victor R, Cha YM, Lin SF, Chen PS. Simultaneous noninvasive recording of skin sympathetic nerve activity and electrocardiogram. Heart Rhythm. 2017 Jan;14(1):25-33. doi: 10.1016/j.hrthm.2016.09.019. Epub 2016 Sep 23.
PMID: 27670627
responsible party type: Sponsor
sharing ipd: Undecided