<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/NCT02226744</url>
  </required_header>
  <id_info>
    <org_study_id>131700</org_study_id>
    <nct_id>NCT02226744</nct_id>
  </id_info>
  <brief_title>Study to Measure Relaxation From Different Types of Focused Breathing Exercises</brief_title>
  <official_title>Focused Breathing Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mind-body practices, such as yoga, ta'i chi, mindfulness and biofeedback, commonly use slow&#xD;
      breathing techniques to induce physiological and mental relaxation. Medical research suggests&#xD;
      that slow breathing techniques induce physiological relaxation. This 6 week study will&#xD;
      compare the effects of different types of breathing. The hypothesis is that different&#xD;
      breathing techniques produce different physiological and mental changes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No funds to complete study as anticipated, preliminary data used for future grant&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Magnitude of changes in heart rate response to upright position</measure>
    <time_frame>10 minutes at baseline, 2 weeks and 6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Magnitude of changes in heart rate variability measured as ratio of low frequency to high frequency ratio components (Hz)</measure>
    <time_frame>Baseline, 2 weeks, and 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnitude of changes in catecholamines in response to upright position</measure>
    <time_frame>10 minutes at baseline, 2 weeks, and 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Breathing</condition>
  <condition>Mind-body Practices</condition>
  <condition>Yoga</condition>
  <condition>Meditation</condition>
  <arm_group>
    <arm_group_label>Focused breathing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Focused deep breathing techniques used to produce specific physiological and psychological states</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Focused breathing 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Focused deep breathing techniques used to produce specific physiological and psychological states</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Focused Breathing</intervention_name>
    <arm_group_label>Focused breathing</arm_group_label>
    <arm_group_label>Focused breathing 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 30 to 50 years&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Heart disease: history of coronary artery disease, myocardial infarction, significant&#xD;
             valvular disease, or congestive heart failure&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Renal Disease&#xD;
&#xD;
          -  Anxiety Disorder&#xD;
&#xD;
          -  Depression&#xD;
&#xD;
          -  Other psychiatric conditions including schizophrenia or bipolar disorder&#xD;
&#xD;
          -  Attention-deficit-disorder or Attention-deficit-hyperactivity disorder&#xD;
&#xD;
          -  Musculoskeletal condition limiting capacity to perform yoga such as chronic lower back&#xD;
             pain, chronic neck pain&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Chronic Obstructive Lung Disease&#xD;
&#xD;
          -  Obstructive Sleep Apnea&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Currently taking blood pressure medications, oral diabetic medication or insulin&#xD;
&#xD;
          -  Current participation in a mind-body practice/program&#xD;
&#xD;
          -  Current cancer other than non-melanoma skin cancer&#xD;
&#xD;
          -  Regular swimmer&#xD;
&#xD;
          -  Plays wind or brass musical instruments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gurjeet S Birdee, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Gurjeet Birdee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>breathing</keyword>
  <keyword>mind-body practices</keyword>
  <keyword>yoga</keyword>
  <keyword>meditation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</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/NCT02226744
org study id: 131700
nct id: NCT02226744
lead sponsor: 
has dmc: No
Mind-body practices, such as yoga, ta'i chi, mindfulness and biofeedback, commonly use slow
      breathing techniques to induce physiological and mental relaxation. Medical research suggests
      that slow breathing techniques induce physiological relaxation. This 6 week study will
      compare the effects of different types of breathing. The hypothesis is that different
      breathing techniques produce different physiological and mental changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Magnitude of changes in heart rate response to upright position
time frame: 10 minutes at baseline, 2 weeks and 6 weeks
measure: Magnitude of changes in heart rate variability measured as ratio of low frequency to high frequency ratio components (Hz)
time frame: Baseline, 2 weeks, and 6 weeks
measure: Magnitude of changes in catecholamines in response to upright position
time frame: 10 minutes at baseline, 2 weeks, and 6 weeks
arm group label: Focused breathing
arm group type: Active Comparator
description: Focused deep breathing techniques used to produce specific physiological and psychological states
arm group label: Focused breathing 2
arm group type: Active Comparator
description: Focused deep breathing techniques used to produce specific physiological and psychological states
intervention type: Behavioral
intervention name: Focused Breathing
arm group label: Focused breathing
arm group label: Focused breathing 2
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gurjeet S Birdee, MD MPH
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Gurjeet Birdee
investigator title: Assistant Professor
mesh term: Respiratory Aspiration