<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/NCT03814980</url>
  </required_header>
  <id_info>
    <org_study_id>17-004445</org_study_id>
    <nct_id>NCT03814980</nct_id>
  </id_info>
  <brief_title>A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients</brief_title>
  <official_title>A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      In this study, a system will be developed to guide patients with chronic obstructive&#xD;
      pulmonary disease (COPD) to complete a mindful breathing practice at home. COPD is the third&#xD;
      leading cause of death in the United States and no cure exists. Shortness of breath is the&#xD;
      most common disabling symptom. Pursed lips breathing is a type of breathing practice that has&#xD;
      demonstrated effectiveness for patients with COPD. It requires practice to maintain and there&#xD;
      is currently no home system to provide the needed feedback and support to maintain PLB.&#xD;
      Additionally, syncing breathing and heart rate variation offers patients additional benefits.&#xD;
      The proposed project explores the use of biofeedback to guide COPD patients in a breathing&#xD;
      practice and to provide data for health coaching to monitor and support the practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Pilot study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Test the feasibility of a mindful breathing application for COPD patients</measure>
    <time_frame>About 1 week</time_frame>
    <description>Mindful Breathing Application on a computer tablet for COPD patients</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>COPD</condition>
  <condition>Emphysema</condition>
  <arm_group>
    <arm_group_label>Pilot Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be shown how to use a mindful breathing software application. The software will be used for 1 week. At the end of the week, participants will evaluate the software.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mindful breathing application</intervention_name>
    <description>Participants will use a mindful breathing application on a computer tablet.</description>
    <arm_group_label>Pilot Study</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>application on a computer tablet</intervention_name>
    <description>a computer tablet</description>
    <arm_group_label>Pilot Study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patients eligible for Pulmonary Rehabilitation will be recruited for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto P Benzo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 3, 2020</last_update_submitted>
  <last_update_submitted_qc>January 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Roberto P. Benzo</investigator_full_name>
    <investigator_title>M.D., Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emphysema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03814980
org study id: 17-004445
nct id: NCT03814980
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, a system will be developed to guide patients with chronic obstructive
      pulmonary disease (COPD) to complete a mindful breathing practice at home. COPD is the third
      leading cause of death in the United States and no cure exists. Shortness of breath is the
      most common disabling symptom. Pursed lips breathing is a type of breathing practice that has
      demonstrated effectiveness for patients with COPD. It requires practice to maintain and there
      is currently no home system to provide the needed feedback and support to maintain PLB.
      Additionally, syncing breathing and heart rate variation offers patients additional benefits.
      The proposed project explores the use of biofeedback to guide COPD patients in a breathing
      practice and to provide data for health coaching to monitor and support the practice.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pilot study
primary purpose: Treatment
masking: None (Open Label)
measure: Test the feasibility of a mindful breathing application for COPD patients
time frame: About 1 week
description: Mindful Breathing Application on a computer tablet for COPD patients
arm group label: Pilot Study
arm group type: Experimental
description: Participants will be shown how to use a mindful breathing software application. The software will be used for 1 week. At the end of the week, participants will evaluate the software.
intervention type: Behavioral
intervention name: mindful breathing application
description: Participants will use a mindful breathing application on a computer tablet.
arm group label: Pilot Study
intervention type: Device
intervention name: application on a computer tablet
description: a computer tablet
arm group label: Pilot Study
criteria: 
gender: All
minimum age: 40 Years
maximum age: 99 Years
healthy volunteers: No
last name: Roberto P Benzo
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Roberto P. Benzo
investigator title: M.D., Associate Professor of Medicine
mesh term: Emphysema
sharing ipd: No