<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/NCT01695525</url>
  </required_header>
  <id_info>
    <org_study_id>12945</org_study_id>
    <nct_id>NCT01695525</nct_id>
  </id_info>
  <brief_title>Influence of Yoga in Patients With Neurocardiogenic Syncope</brief_title>
  <acronym>SYNC - YOGA</acronym>
  <official_title>Neurocardiogenic Syncope and the Role That Yoga Plays in People With Autonomic Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dhanunjaya Lakkireddy, MD, FACC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Syncope is a common problem that many clinicians may encounter in various outpatient&#xD;
      settings. Neurocardiogenic syncope (NCS) is a benign condition characterized by a self&#xD;
      limited episode of systemic hypotension. Patients are usually managed with education on&#xD;
      syncope, anxiety management, and coping skills.&#xD;
&#xD;
      It has been established that practice of Yoga could relieve stress and anxiety. In a&#xD;
      different study, they also found that Yoga positively influences cardiovascular function by&#xD;
      decreasing the heart rate and blood pressure. The main objective of Yoga is to achieve&#xD;
      control over the autonomic nervous system and able to control functions like heart rate,&#xD;
      blood pressure and respiratory rate.&#xD;
&#xD;
      Based on the findings that Yoga relieves stress and reduces heart rate, the investigators&#xD;
      propose to study if Yoga can decrease the frequency of NCS and also reduce the symptoms&#xD;
      associated with these episodes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Early Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)</measure>
    <time_frame>Baseline to 3 Months</time_frame>
    <description>Differences in the incidence of syncopal spells pre and post Yoga.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)</measure>
    <time_frame>Baseline to 1 Year</time_frame>
    <description>Differences in the incidence of syncopal spells pre and post Yoga.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)</measure>
    <time_frame>Baseline to 1 Year</time_frame>
    <description>Differences in the incidence of syncopal symptoms pre and post Yoga.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Heart Health</measure>
    <time_frame>3 Months, 1 Year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Syncope, Vasovagal</condition>
  <arm_group>
    <arm_group_label>Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to practice Yoga 3 times per week at a minimum, and daily at a maximum. Participants will receive training in different Yoga techniques including breathing exercises, postures and meditation. Participants will be asked to practice 1 hour Yoga sessions comprised of breathing exercises, postures and meditation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>Includes breathing exercises, postures, and meditation. Participant practices yoga at their home a minimum of 3 times per week for 1 hour per time. Participation can last for up to 1 year.</description>
    <arm_group_label>Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of recurrent Neurocardiogenic syncope&#xD;
&#xD;
          -  At least one episode of syncope or pre-syncopal event in the last 3 months prior to&#xD;
             enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously established diagnosis of any psychiatric illness.&#xD;
&#xD;
          -  Previous history of Coronary Artery Disease, myocardial infarction, congestive heart&#xD;
             failure, carotid sinus hypersensitivity&#xD;
&#xD;
          -  Established diagnosis of tachy and/or brady arrhythmias, except cardioinhibiotry&#xD;
             neurocardiogenic syncope.&#xD;
&#xD;
          -  History of pacemaker, ICD or CRT-D implantation.&#xD;
&#xD;
          -  Other conditions where Yoga should be avoided are:&#xD;
&#xD;
               1. Pregnant women&#xD;
&#xD;
               2. Subjects with untreated or uncontrolled high blood pressure&#xD;
&#xD;
               3. Subjects with past history of Pnuemothorax.&#xD;
&#xD;
               4. Subjects with severe cervical spondylitis and cervical, thoracic or lumbar disc&#xD;
                  prolapse.&#xD;
&#xD;
               5. Subjects with carotid stenosis&#xD;
&#xD;
               6. Subjects with history of psychosis (evidence of acute episodes with deep and&#xD;
                  prolonged meditation) or substance abuse.&#xD;
&#xD;
               7. Subjects with the history of epilepsy ( evidence of acute episodes with deep and&#xD;
                  prolonged meditation)&#xD;
&#xD;
               8. Subjects with glaucoma&#xD;
&#xD;
               9. Subjects with history of Total Hip Replacement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dhanunjaya Lakkireddy, MD, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>June 27, 2015</last_update_submitted>
  <last_update_submitted_qc>June 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Dhanunjaya Lakkireddy, MD, FACC</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Neurocardiogenic Syncope</keyword>
  <keyword>Yoga</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syncope</mesh_term>
    <mesh_term>Syncope, Vasovagal</mesh_term>
  </condition_browse>
  <!-- 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/NCT01695525
org study id: 12945
nct id: NCT01695525
lead sponsor: 
has dmc: No
Syncope is a common problem that many clinicians may encounter in various outpatient
      settings. Neurocardiogenic syncope (NCS) is a benign condition characterized by a self
      limited episode of systemic hypotension. Patients are usually managed with education on
      syncope, anxiety management, and coping skills.

      It has been established that practice of Yoga could relieve stress and anxiety. In a
      different study, they also found that Yoga positively influences cardiovascular function by
      decreasing the heart rate and blood pressure. The main objective of Yoga is to achieve
      control over the autonomic nervous system and able to control functions like heart rate,
      blood pressure and respiratory rate.

      Based on the findings that Yoga relieves stress and reduces heart rate, the investigators
      propose to study if Yoga can decrease the frequency of NCS and also reduce the symptoms
      associated with these episodes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
time frame: Baseline to 3 Months
description: Differences in the incidence of syncopal spells pre and post Yoga.
measure: Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
time frame: Baseline to 1 Year
description: Differences in the incidence of syncopal spells pre and post Yoga.
measure: Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
time frame: Baseline to 1 Year
description: Differences in the incidence of syncopal symptoms pre and post Yoga.
measure: Change in Heart Health
time frame: 3 Months, 1 Year
arm group label: Yoga
arm group type: Experimental
description: Participants will be asked to practice Yoga 3 times per week at a minimum, and daily at a maximum. Participants will receive training in different Yoga techniques including breathing exercises, postures and meditation. Participants will be asked to practice 1 hour Yoga sessions comprised of breathing exercises, postures and meditation.
intervention type: Other
intervention name: Yoga
description: Includes breathing exercises, postures, and meditation. Participant practices yoga at their home a minimum of 3 times per week for 1 hour per time. Participation can last for up to 1 year.
arm group label: Yoga
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Dhanunjaya Lakkireddy, MD, FACC
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Dhanunjaya Lakkireddy, MD, FACC
investigator title: Professor of Medicine
mesh term: Syncope
mesh term: Syncope, Vasovagal