xml: <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/NCT05973513</url>
    </required_header>
    <id_info>
      <org_study_id>21-000741-B</org_study_id>
      <nct_id>NCT05973513</nct_id>
    </id_info>
    <brief_title>Open Trial of Biofeedback for Respiratory Symptoms</brief_title>
    <official_title>Open Trial of Biofeedback for Respiratory Symptoms</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Los Angeles</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Los Angeles</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>
        Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control&#xD;
        over previously unrecognized sympathetic changes such as body temperature, blood pressure,&#xD;
        and heart rate. We propose to use a six session biofeedback protocol that includes heart-rate&#xD;
        variability (HRV) biofeedback, respiration/relaxation training, and body temperature control&#xD;
        to treat patients with unaddressed respiratory symptoms (e.g. shortness of breath) who are&#xD;
        under the care of pulmonologists and have not responded to traditional biomedical approaches&#xD;
        (e.g. inhalers, pulmonary rehab, etc.).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control&#xD;
        over previously unrecognized sympathetic changes such as body temperature, blood pressure,&#xD;
        and heart rate. Through a series of mind-body techniques, patients are taught to reduce&#xD;
        sympathetic responses, leading to self-regulation over physiological responses that affect&#xD;
        somatic sensitivity. The investigators propose to use a six session biofeedback protocol that&#xD;
        includes heart-rate variability (HRV) biofeedback, respiration/relaxation training, and body&#xD;
        temperature control to treat patients with unaddressed respiratory symptoms (e.g. shortness&#xD;
        of breath) who are under the care of pulmonologists and have not responded to traditional&#xD;
        biomedical approaches (e.g. inhalers, pulmonary rehab, etc.). The aim of the study is to&#xD;
        determine whether patients who complete a six-session biofeedback protocol report a decrease&#xD;
        in somatic symptoms, and improvements in self-rated mental health (depression, anxiety,&#xD;
        quality of life) after the program and at three-months follow-up. The investigators will also&#xD;
        study whether these improvements are also related to reduced healthcare utilization.&#xD;
  &#xD;
        The investigators plan to recruit up to 100 participants in the study. Participants who are&#xD;
        screened as eligible for biofeedback for their physical ailments or psychological complaints&#xD;
        will be asked complete a set of questionnaires before, after, and three months'&#xD;
        post-treatment to evaluate the utility of the biofeedback treatment protocol. These&#xD;
        questionnaires will be available online and will be completed from home. Participants who are&#xD;
        eligible to participate but cannot complete questionnaires from home will be given the option&#xD;
        of completing the questionnaires in the office before the first biofeedback session.&#xD;
        Participants that cannot be immediately enrolled in the protocol due to scheduling reasons&#xD;
        will be asked to complete the questionnaires at recruitment to serve as wait-list controls.&#xD;
        They will complete the same consent as other participants. The investigators anticipate that&#xD;
        questionnaires will take 30 minutes to complete, totaling about 90 minutes for participants&#xD;
        immediately enrolled and 120 minutes for wait-list controls.&#xD;
  &#xD;
        Each biofeedback session will take 1 hour each. Session 1 of biofeedback will present the&#xD;
        rationale and evidence for the treatment, teach breathing techniques, and introduce the&#xD;
        biofeedback sensors for respiration, heart rate and temperature using the Biotrace software.&#xD;
        The session will focus on breathing rate practice. Session 2 will introduce heart rate&#xD;
        variability (HRV), cover breathing rhythm, and focus on the completion Resonance Frequency&#xD;
        Assessment, an exercise to identify a participant's ideal breath rate for sustaining HRV.&#xD;
        Session 3 will continue HRV practice using a separate software with video games, Alive.&#xD;
        Session 4 will repeat session 3 but with more challenging practice of HRV video games.&#xD;
        Session 5 will continue HRV practice in the first software (Biotrace) then will introduce&#xD;
        participants to temperature control. Session 6 will repeat Session 5 but with more&#xD;
        challenging practice for temperature control. Total time for participation will be&#xD;
        approximately seven hours across three to six months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in score on the PHQ-9</measure>
      <time_frame>After six week protocol and 3 months after six week protcol</time_frame>
      <description>Improvement in self-rated depressive sx on the PHQ-9</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in score on the GAD-7</measure>
      <time_frame>After six week protocol and 3 months after six week protcol</time_frame>
      <description>Improvement in self-rated anxiety sx on the GAD-7</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in score on the SF-36</measure>
      <time_frame>After six week protocol and 3 months after six week protcol</time_frame>
      <description>Improvement in self-rated QOL on the SF-36</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in score on the PHQ-15</measure>
      <time_frame>After six week protocol and 3 months after six week protcol</time_frame>
      <description>Improvement in self-rated physical symptoms on the PHQ-15</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in score on the PSQI</measure>
      <time_frame>After six week protocol and 3 months after six week protcol</time_frame>
      <description>Improvement in self-rated sleep quality and duration on the PSQI</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in score on the St George's Respiratory Questionnaire (SGRQ)</measure>
      <time_frame>After six week protocol and 3 months after six week protcol</time_frame>
      <description>Improvement in self-rated respiratory sx on the SGRQ</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in healthcare utilization</measure>
      <time_frame>After six week protocol and 3 months after six week protcol</time_frame>
      <description>Reduced healthcare utilization: Fewer medical visits and use of prescription and OTC meds in last month</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Shortness of Breath/Dyspnea</condition>
    <arm_group>
      <arm_group_label>Immediate Enrollment</arm_group_label>
      <description>We propose to study whether patients who complete a clinical six-session biofeedback protocol will demonstrate improvements in mental and physical health.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          (1) participants must be between 18-60; (2) English speaking; (3) must have least one&#xD;
          respiratory sx and have received care from a pulmonologist for this sx&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. participants must be between 18-60&#xD;
  &#xD;
            2. English speaking&#xD;
  &#xD;
            3. must have least one respiratory sx and have received care from a pulmonologist for&#xD;
               this sx&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          severe psychopathology (e.g., psychosis, active suicidality, moderate to severe&#xD;
          intellectual impairment).&#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_contact>
      <last_name>Natacha D Emerson, PhD</last_name>
      <phone>310-794-8416</phone>
      <email>ndemerson@mednet.ucla.edu</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
      <investigator_full_name>Natacha D. Emerson</investigator_full_name>
      <investigator_title>Assistant Clinical Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyspnea</mesh_term>
      <mesh_term>Signs and Symptoms, Respiratory</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 14, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT05973513/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973513
  org study id: 21-000741-B
  nct id: NCT05973513
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control
        over previously unrecognized sympathetic changes such as body temperature, blood pressure,
        and heart rate. We propose to use a six session biofeedback protocol that includes heart-rate
        variability (HRV) biofeedback, respiration/relaxation training, and body temperature control
        to treat patients with unaddressed respiratory symptoms (e.g. shortness of breath) who are
        under the care of pulmonologists and have not responded to traditional biomedical approaches
        (e.g. inhalers, pulmonary rehab, etc.).
  Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control
        over previously unrecognized sympathetic changes such as body temperature, blood pressure,
        and heart rate. Through a series of mind-body techniques, patients are taught to reduce
        sympathetic responses, leading to self-regulation over physiological responses that affect
        somatic sensitivity. The investigators propose to use a six session biofeedback protocol that
        includes heart-rate variability (HRV) biofeedback, respiration/relaxation training, and body
        temperature control to treat patients with unaddressed respiratory symptoms (e.g. shortness
        of breath) who are under the care of pulmonologists and have not responded to traditional
        biomedical approaches (e.g. inhalers, pulmonary rehab, etc.). The aim of the study is to
        determine whether patients who complete a six-session biofeedback protocol report a decrease
        in somatic symptoms, and improvements in self-rated mental health (depression, anxiety,
        quality of life) after the program and at three-months follow-up. The investigators will also
        study whether these improvements are also related to reduced healthcare utilization.
  
        The investigators plan to recruit up to 100 participants in the study. Participants who are
        screened as eligible for biofeedback for their physical ailments or psychological complaints
        will be asked complete a set of questionnaires before, after, and three months'
        post-treatment to evaluate the utility of the biofeedback treatment protocol. These
        questionnaires will be available online and will be completed from home. Participants who are
        eligible to participate but cannot complete questionnaires from home will be given the option
        of completing the questionnaires in the office before the first biofeedback session.
        Participants that cannot be immediately enrolled in the protocol due to scheduling reasons
        will be asked to complete the questionnaires at recruitment to serve as wait-list controls.
        They will complete the same consent as other participants. The investigators anticipate that
        questionnaires will take 30 minutes to complete, totaling about 90 minutes for participants
        immediately enrolled and 120 minutes for wait-list controls.
  
        Each biofeedback session will take 1 hour each. Session 1 of biofeedback will present the
        rationale and evidence for the treatment, teach breathing techniques, and introduce the
        biofeedback sensors for respiration, heart rate and temperature using the Biotrace software.
        The session will focus on breathing rate practice. Session 2 will introduce heart rate
        variability (HRV), cover breathing rhythm, and focus on the completion Resonance Frequency
        Assessment, an exercise to identify a participant's ideal breath rate for sustaining HRV.
        Session 3 will continue HRV practice using a separate software with video games, Alive.
        Session 4 will repeat session 3 but with more challenging practice of HRV video games.
        Session 5 will continue HRV practice in the first software (Biotrace) then will introduce
        participants to temperature control. Session 6 will repeat Session 5 but with more
        challenging practice for temperature control. Total time for participation will be
        approximately seven hours across three to six months.
  observational model: Case-Only
  time perspective: Prospective
  measure: Change in score on the PHQ-9
  time frame: After six week protocol and 3 months after six week protcol
  description: Improvement in self-rated depressive sx on the PHQ-9
  measure: Change in score on the GAD-7
  time frame: After six week protocol and 3 months after six week protcol
  description: Improvement in self-rated anxiety sx on the GAD-7
  measure: Change in score on the SF-36
  time frame: After six week protocol and 3 months after six week protcol
  description: Improvement in self-rated QOL on the SF-36
  measure: Change in score on the PHQ-15
  time frame: After six week protocol and 3 months after six week protcol
  description: Improvement in self-rated physical symptoms on the PHQ-15
  measure: Change in score on the PSQI
  time frame: After six week protocol and 3 months after six week protcol
  description: Improvement in self-rated sleep quality and duration on the PSQI
  measure: Change in score on the St George's Respiratory Questionnaire (SGRQ)
  time frame: After six week protocol and 3 months after six week protcol
  description: Improvement in self-rated respiratory sx on the SGRQ
  measure: Change in healthcare utilization
  time frame: After six week protocol and 3 months after six week protcol
  description: Reduced healthcare utilization: Fewer medical visits and use of prescription and OTC meds in last month
  arm group label: Immediate Enrollment
  description: We propose to study whether patients who complete a clinical six-session biofeedback protocol will demonstrate improvements in mental and physical health.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Natacha D Emerson, PhD
  phone: 310-794-8416
  email: ndemerson@mednet.ucla.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Los Angeles
  investigator full name: Natacha D. Emerson
  investigator title: Assistant Clinical Professor
  mesh term: Dyspnea
  mesh term: Signs and Symptoms, Respiratory
  provided document: 