<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/NCT03039231</url>
  </required_header>
  <id_info>
    <org_study_id>P-16-FS02</org_study_id>
    <nct_id>NCT03039231</nct_id>
  </id_info>
  <brief_title>Investigation of the Freespira Breathing System in the Treatment of Post Traumatic Stress Disorder (PTSD)</brief_title>
  <official_title>Investigation of the Freespira Breathing System in the Treatment of PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Palo Alto Health Sciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Palo Alto Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Palo Alto Health Sciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test the efficacy of the Freespira Breathing System in adults with post&#xD;
      traumatic stress disorder (PTSD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a&#xD;
      portable home device , and has been employed in breathing biofeedback in adults with panic&#xD;
      disorder (PD). The FBS has received FDA clearance for the treatment of PD adults and is&#xD;
      currently commercially available.&#xD;
&#xD;
      This study is a prospective, single arm, un-blinded investigation of the Freespira Breathing&#xD;
      System in the PTSD population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">August 25, 2019</completion_date>
  <primary_completion_date type="Actual">April 24, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary outcome of this study will be quantitative improvements using the Clinician Administered PTSD Scale (CAPS - 5).</measure>
    <time_frame>2 month and 6 months post treatment</time_frame>
    <description>Using this scale, Response is defined as a reduction of 6 or more points. Remission is defined as Response plus no longer meeting clinical symptom criteria and having a severity score &lt; 25.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Health Questionnaire (PHQ-9) Score</measure>
    <time_frame>2 month and 6 months post treatment</time_frame>
    <description>Change in condition (score) as recorded from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 36-Item Short Form Survey (SF-36) Score</measure>
    <time_frame>2 month and 6 months post treatment</time_frame>
    <description>Change in condition (score) as recorded from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Global Impression (CGC-S) Score</measure>
    <time_frame>2 month and 6 months post treatment</time_frame>
    <description>Change in condition (score) as recorded from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Panic Disorder and Severity Scale (PDSS) Score</measure>
    <time_frame>2 month and 6 months post treatment</time_frame>
    <description>Proportion achieving a clinically significant 40% decrease, proportion achieving a remission score &lt;= 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion achieving &quot;Remission&quot; by CAPS-5 Score</measure>
    <time_frame>2 month and 6 months post treatment</time_frame>
    <description>Remission is defined as 'Response' plus no longer meeting clinical symptom criteria and having a severity score of &lt;25.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Stress Disorders, Post-Traumatic</condition>
  <arm_group>
    <arm_group_label>Freespira Breathing System (FBS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device used for breathing biofeedback in adults with panic disorder (PD). FBS has received FDA clearance for the treatment of PD adults and is currently commercially available with more than 150 therapist providing the treatment nationally. FBS has not yet been tested for efficacy in an adult post traumatic stress disorder (PTSD) population. It has been suggested that there is overlap in the presence and persistence of symptoms between PD and PTSD patients. The primary goal of this study is to determine whether the FBS will produce similar benefit (both in quality and magnitude) in the defined population of patients with PTSD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Freespira Breathing System</intervention_name>
    <description>Following authorization from a study team member, patient will be assigned an FBS to take home and perform 4 weeks of training exercises twice a day for 17 minutes each time. Efficacy of the FBS system will be evaluate over the 4 week period and at 2 and 6 month follow-up periods.</description>
    <arm_group_label>Freespira Breathing System (FBS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Note: Office visits required. Patients must live locally in San Francisco/Silicon Valley&#xD;
        Bay Area to participate.&#xD;
&#xD;
        Patients with a primary diagnosis of PTSD&#xD;
&#xD;
          -  Additional DSM-V disorders are acceptable and will be documented.&#xD;
&#xD;
               -  Subjects over 18 years of age&#xD;
&#xD;
               -  Subjects with a Clinician's Global Impression (CGI-S) score of ≥ 4&#xD;
&#xD;
               -  Subjects with a CAPS-5 score of ≥ 30&#xD;
&#xD;
               -  If on psychotropic medication(s), on a stable dose during the course of treatment&#xD;
&#xD;
          -  This can include benzodiazepine use that is prescribed on an as needed basis. • If on&#xD;
             psychotropic medication(s), patient agreement to maintain their current stable dose&#xD;
             from point of study entry until the 2-month post-treatment assessment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is pregnant.&#xD;
&#xD;
          -  Current enrollment in another device or drug study.&#xD;
&#xD;
          -  Enrollment in another drug or device study that is not at least 30 days past the final&#xD;
             follow-up visit.&#xD;
&#xD;
          -  Currently undergoing cognitive behavioral therapy, or equivalent that is focused&#xD;
             addressing PTSD including any evidenced based therapy that focuses on PTSD, including&#xD;
             cognitive processing therapy, EMDR, prolonged exposure therapy, Virtual reality&#xD;
             therapy, during trial and 2 month follow up. Cognitive therapy must be discontinued 1&#xD;
             month prior to enrolling in this study.&#xD;
&#xD;
          -  Severe suicidality, in the judgment of the interviewer and taking the CHART assessment&#xD;
             into account&#xD;
&#xD;
          -  Psychotic disorder diagnosis, including schizophrenia and schizoaffective disorder&#xD;
&#xD;
          -  Presence of uncontrolled bipolar disorder as described below -&#xD;
&#xD;
               -  The subject has experienced a manic episode in the past 6 months and is not&#xD;
                  considered under control by reviewer&#xD;
&#xD;
               -  Bipolar disorder is considered the primary diagnosis for the subject, in the&#xD;
                  interviewer's opinion.&#xD;
&#xD;
          -  No Alcohol, drug use disorder that requires medical treatment . If stable under&#xD;
             medical supervision treatment for drug/alcohol use, then OK&#xD;
&#xD;
          -  Cardiovascular or pulmonary disease, such as COPD.&#xD;
&#xD;
               -  Score of ≥ 10 on the COPD assessment&#xD;
&#xD;
               -  EtCO2 of ≥ 48 mmHg at first treatment visit&#xD;
&#xD;
          -  Epilepsy or seizures&#xD;
&#xD;
          -  Inability to understand or comply with study procedures.&#xD;
&#xD;
          -  The investigator feels that for any reason the subject is not eligible to participate&#xD;
             in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Ostacher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Palo Alto Health Care System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine/Palo Alto Veterans Institute for Research</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.freespira.com</url>
    <description>For more information about the Freespira Breathing System click on link</description>
  </link>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PTSD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT03039231
org study id: P-16-FS02
nct id: NCT03039231
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study will test the efficacy of the Freespira Breathing System in adults with post
      traumatic stress disorder (PTSD).
The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a
      portable home device , and has been employed in breathing biofeedback in adults with panic
      disorder (PD). The FBS has received FDA clearance for the treatment of PD adults and is
      currently commercially available.

      This study is a prospective, single arm, un-blinded investigation of the Freespira Breathing
      System in the PTSD population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary outcome of this study will be quantitative improvements using the Clinician Administered PTSD Scale (CAPS - 5).
time frame: 2 month and 6 months post treatment
description: Using this scale, Response is defined as a reduction of 6 or more points. Remission is defined as Response plus no longer meeting clinical symptom criteria and having a severity score < 25.
measure: Change in Patient Health Questionnaire (PHQ-9) Score
time frame: 2 month and 6 months post treatment
description: Change in condition (score) as recorded from baseline
measure: Change in 36-Item Short Form Survey (SF-36) Score
time frame: 2 month and 6 months post treatment
description: Change in condition (score) as recorded from baseline
measure: Change in Clinical Global Impression (CGC-S) Score
time frame: 2 month and 6 months post treatment
description: Change in condition (score) as recorded from baseline
measure: Change in Panic Disorder and Severity Scale (PDSS) Score
time frame: 2 month and 6 months post treatment
description: Proportion achieving a clinically significant 40% decrease, proportion achieving a remission score <= 5.
measure: Proportion achieving "Remission" by CAPS-5 Score
time frame: 2 month and 6 months post treatment
description: Remission is defined as 'Response' plus no longer meeting clinical symptom criteria and having a severity score of <25.
arm group label: Freespira Breathing System (FBS)
arm group type: Experimental
description: The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device used for breathing biofeedback in adults with panic disorder (PD). FBS has received FDA clearance for the treatment of PD adults and is currently commercially available with more than 150 therapist providing the treatment nationally. FBS has not yet been tested for efficacy in an adult post traumatic stress disorder (PTSD) population. It has been suggested that there is overlap in the presence and persistence of symptoms between PD and PTSD patients. The primary goal of this study is to determine whether the FBS will produce similar benefit (both in quality and magnitude) in the defined population of patients with PTSD.
intervention type: Device
intervention name: Freespira Breathing System
description: Following authorization from a study team member, patient will be assigned an FBS to take home and perform 4 weeks of training exercises twice a day for 17 minutes each time. Efficacy of the FBS system will be evaluate over the 4 week period and at 2 and 6 month follow-up periods.
arm group label: Freespira Breathing System (FBS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael J Ostacher, MD
role: Principal Investigator
affiliation: VA Palo Alto Health Care System
facility: 
country: United States
url: http://www.freespira.com
description: For more information about the Freespira Breathing System click on link
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No