<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/NCT03779269</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-13-0045-CR03</org_study_id>
    <nct_id>NCT03779269</nct_id>
  </id_info>
  <brief_title>Effect of Preksha Meditation on Cognitive Abilities and Pulmonary Function in Students</brief_title>
  <official_title>Effect of Preksha Meditation (Green Color and Buzzing Meditation) on Cognitive Abilities and Pulmonary Function in Students With a Control Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orlando Regional Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Florida International University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Orlando Regional Medical Center</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 project is to assess impact of an 8 week course of Preksha Meditation&#xD;
      (combination of Green color and buzzing sound meditation), in a group of college students to&#xD;
      assess potential benefits to their pulmonary function, cognitive ability (immediate recall,&#xD;
      attention), and happiness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preksha Meditation Research: The goal of this project is to assess impact of an 8 week course&#xD;
      of Preksha Meditation (combination of Green color and buzzing sound meditation), in a group&#xD;
      of college students to assess potential benefits to their pulmonary function, cognitive&#xD;
      ability (immediate recall, attention), and happiness. The investigators will compare the data&#xD;
      received from prior study to analyze their performance before and after. The investigators&#xD;
      will also compare this data with control group data, to assess potential improvements as a&#xD;
      benchmark. Analyse the EEG data to investigate its impact on brain. Further analyze their&#xD;
      blood cells if they show any epigenetic changes. Data analysis team will be blinded for no&#xD;
      identifiers are available.&#xD;
&#xD;
      METHOD AND PROCEDURES:&#xD;
&#xD;
      The data analysis will be undertaken by experts and will be blinded. The data currently is&#xD;
      only de-identified.&#xD;
&#xD;
      The data which is already collected from the research &quot;Effect of Preksha Meditation (Green&#xD;
      color and Buzzing Meditation) on Cognitive Abilities and Pulmonary Function in Students with&#xD;
      a Control Group&quot; will be analyzed. The data is related to students having practiced minimum 3&#xD;
      guided 25 minute sessions per week in a controlled environment. The control group did not&#xD;
      meditate for those weeks when they enrolled in the program.&#xD;
&#xD;
      The intervention the subjects received was as follows:&#xD;
&#xD;
      Experimental group 3 days per week Sessions: 5 minutes: Relaxation and Review of Meditation&#xD;
      Practices 10 minutes: Mahapraan Meditation 10 minutes: Green color meditation Begin in stages&#xD;
&#xD;
        -  0 - 2 Weeks: Teach technique and carry out 15 minutes meditation sessions.&#xD;
&#xD;
        -  2 - 9 Weeks: Increment meditation sessions to a length of 25 minutes. 5 minutes: Review&#xD;
           of meditation experience and collection of information&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 14, 2017</start_date>
  <completion_date type="Anticipated">December 14, 2025</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>prospective convenience controlled study</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive skills assessment using Connor's CPT test</measure>
    <time_frame>8 weeks</time_frame>
    <description>Affect, short term memory, inattention,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function using actual lung capacity test</measure>
    <time_frame>8 weeks</time_frame>
    <description>Spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transcriptomics and epigenetics</measure>
    <time_frame>8 weeks</time_frame>
    <description>Upregulation and transcriptional profiling using fold change</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>Inattention and Memory</condition>
  <condition>Affect</condition>
  <arm_group>
    <arm_group_label>color meditation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>only color meditation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sound meditation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Only sound mediation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Color and sound combined meditation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combined group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>meditation</intervention_name>
    <description>meditation effect assessment using assessment tools.</description>
    <arm_group_label>Color and sound combined meditation</arm_group_label>
    <arm_group_label>Sound meditation</arm_group_label>
    <arm_group_label>color meditation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy individuals&#xD;
&#xD;
          -  No prior experience in meditation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior experience with meditation.&#xD;
&#xD;
               -  health issues.&#xD;
&#xD;
               -  Alcohol&#xD;
&#xD;
               -  Smoking.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Devendra Mehta, M.D., M. SC.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head, Translational Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida International University</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Regional Medical Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mehta S, Mehta V, Mehta S, Shah D, Motiwala A, Vardhan J, Mehta N, Mehta D. Multimodal behavior program for ADHD incorporating yoga and implemented by high school volunteers: a pilot study. ISRN Pediatr. 2011;2011:780745. doi: 10.5402/2011/780745. Epub 2011 Aug 11.</citation>
    <PMID>22389788</PMID>
  </reference>
  <reference>
    <citation>Pragya SU, Cordoba G, Chiu R, Mehta N, Johnson P, Mehta DI, Mehta N. Can The Cognitive Parameters Of College Students With Learning Disabilities Benefit From Using Mahapraan, A Breathing Based Preksha Meditation. Journal of College Teaching &amp; Learning 2014; 11, 4 Epub</citation>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 19, 2022</last_update_submitted>
  <last_update_submitted_qc>September 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Orlando Regional Medical Center</investigator_affiliation>
    <investigator_full_name>Devendra Mehta</investigator_full_name>
    <investigator_title>Director Translational Research laboratory</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>De-identified summary data</ipd_description>
  </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/NCT03779269
org study id: IRB-13-0045-CR03
nct id: NCT03779269
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this project is to assess impact of an 8 week course of Preksha Meditation
      (combination of Green color and buzzing sound meditation), in a group of college students to
      assess potential benefits to their pulmonary function, cognitive ability (immediate recall,
      attention), and happiness.
Preksha Meditation Research: The goal of this project is to assess impact of an 8 week course
      of Preksha Meditation (combination of Green color and buzzing sound meditation), in a group
      of college students to assess potential benefits to their pulmonary function, cognitive
      ability (immediate recall, attention), and happiness. The investigators will compare the data
      received from prior study to analyze their performance before and after. The investigators
      will also compare this data with control group data, to assess potential improvements as a
      benchmark. Analyse the EEG data to investigate its impact on brain. Further analyze their
      blood cells if they show any epigenetic changes. Data analysis team will be blinded for no
      identifiers are available.

      METHOD AND PROCEDURES:

      The data analysis will be undertaken by experts and will be blinded. The data currently is
      only de-identified.

      The data which is already collected from the research "Effect of Preksha Meditation (Green
      color and Buzzing Meditation) on Cognitive Abilities and Pulmonary Function in Students with
      a Control Group" will be analyzed. The data is related to students having practiced minimum 3
      guided 25 minute sessions per week in a controlled environment. The control group did not
      meditate for those weeks when they enrolled in the program.

      The intervention the subjects received was as follows:

      Experimental group 3 days per week Sessions: 5 minutes: Relaxation and Review of Meditation
      Practices 10 minutes: Mahapraan Meditation 10 minutes: Green color meditation Begin in stages

        -  0 - 2 Weeks: Teach technique and carry out 15 minutes meditation sessions.

        -  2 - 9 Weeks: Increment meditation sessions to a length of 25 minutes. 5 minutes: Review
           of meditation experience and collection of information
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: prospective convenience controlled study
primary purpose: Basic Science
masking: None (Open Label)
measure: Cognitive skills assessment using Connor's CPT test
time frame: 8 weeks
description: Affect, short term memory, inattention,
measure: Pulmonary function using actual lung capacity test
time frame: 8 weeks
description: Spirometry
measure: Transcriptomics and epigenetics
time frame: 8 weeks
description: Upregulation and transcriptional profiling using fold change
arm group label: color meditation
arm group type: Experimental
description: only color meditation
arm group label: Sound meditation
arm group type: Experimental
description: Only sound mediation
arm group label: Color and sound combined meditation
arm group type: Experimental
description: Combined group
arm group label: Control group
arm group type: No Intervention
description: Only control group
intervention type: Other
intervention name: meditation
description: meditation effect assessment using assessment tools.
arm group label: Color and sound combined meditation
arm group label: Sound meditation
arm group label: color meditation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Devendra Mehta, M.D., M. SC.
role: Principal Investigator
affiliation: Head, Translational Research
facility: 
facility: 
country: United States
citation: Mehta S, Mehta V, Mehta S, Shah D, Motiwala A, Vardhan J, Mehta N, Mehta D. Multimodal behavior program for ADHD incorporating yoga and implemented by high school volunteers: a pilot study. ISRN Pediatr. 2011;2011:780745. doi: 10.5402/2011/780745. Epub 2011 Aug 11.
PMID: 22389788
citation: Pragya SU, Cordoba G, Chiu R, Mehta N, Johnson P, Mehta DI, Mehta N. Can The Cognitive Parameters Of College Students With Learning Disabilities Benefit From Using Mahapraan, A Breathing Based Preksha Meditation. Journal of College Teaching & Learning 2014; 11, 4 Epub
responsible party type: Principal Investigator
investigator affiliation: Orlando Regional Medical Center
investigator full name: Devendra Mehta
investigator title: Director Translational Research laboratory
sharing ipd: No
ipd description: De-identified summary data