Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of the Freespira Breathing System in the Treatment of Post Traumatic Stress Disorder (PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03039231
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Palo Alto Health Sciences, Inc.

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE February 1, 2017
Last Update Posted Date April 17, 2018
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
Primary outcome of this study will be quantitative improvements using the Clinician Administered PTSD Scale (CAPS). [ Time Frame: 2 month and 6 months post treatment ]
Using this scale, Response is defined as a reduction of 10 or more points. Loss of diagnosis is defined as Response plus no longer meeting CAPS "1/2" symptom criteria and having a severity score < 45. Remission is defined as Loss of Diagnosis plus a severity score < 20.
Change History Complete list of historical versions of study NCT03039231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • Change in Patient Health Questionnaire (PHQ-9) Score [ Time Frame: 2 month and 6 months post treatment ]
    Change in condition (score) as recorded from baseline
  • Change in 36-Item Short Form Survey (SF-36) Score [ Time Frame: 2 month and 6 months post treatment ]
    Change in condition (score) as recorded from baseline
  • Change in Clinical Global Impression (CGC-S) Score [ Time Frame: 2 month and 6 months post treatment ]
    Change in condition (score) as recorded from baseline
  • Change in Panic Disorder and Severity Scale (PDSS) Score [ Time Frame: 2 month and 6 months post treatment ]
    Proportion achieving a clinically significant 40% decrease, proportion achieving a remission score <= 5.
  • Proportion achieving "Remission" by CAPS-5 Score [ Time Frame: 2 month and 6 months post treatment ]
    Remission is defined as 'Response' plus no longer meeting clinical symptom criteria and having a severity score of <25.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
  • Change in Patient Health Questionnaire (PHQ-9) Score [ Time Frame: 2 month and 6 months post treatment ]
    Change in condition (score) as recorded from baseline
  • Change in 36-Item Short Form Survey (SF-36) Score [ Time Frame: 2 month and 6 months post treatment ]
    Change in condition (score) as recorded from baseline
  • Change in Clinical Global Impression (CGC-S) Score [ Time Frame: 2 month and 6 months post treatment ]
    Change in condition (score) as recorded from baseline
  • Change in Panic Disorder and Severity Scale (PDSS) Score [ Time Frame: 2 month and 6 months post treatment ]
    Proportion achieving a clinically significant 40% decrease, proportion achieving a remission score <5.
  • Proportion achieving "Loss of Diagnosis" by CAPS Score [ Time Frame: 2 month and 6 months post treatment ]
    Loss of diagnosis is defined as 'Response' plus no longer meeting CAPS "1/2" symptom criteria and having a severity score of <45.
  • Proportion achieving "Remission" by CAPS Score [ Time Frame: 2 month and 6 months post treatment ]
    Remission is defined as 'Loss of Diagnosis' plus a severity score of <20.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Freespira Breathing System in the Treatment of Post Traumatic Stress Disorder (PTSD)
Official Title  ICMJE Investigation of the Freespira Breathing System in the Treatment of PTSD
Brief Summary This study will test the efficacy of the Freespira Breathing System in adults with post traumatic stress disorder (PTSD).
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stress Disorders, Post-Traumatic
Intervention  ICMJE Device: Freespira Breathing System
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.
Study Arms  ICMJE Experimental: Freespira Breathing System (FBS)
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: Device: Freespira Breathing System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2017)
55
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Note: Office visits required. Patients must live locally in San Francisco/Silicon Valley Bay Area to participate.

Patients with a primary diagnosis of PTSD

  • Additional DSM-V disorders are acceptable and will be documented.

    • Subjects over 18 years of age
    • Subjects with a Clinician's Global Impression (CGI-S) score of ≥ 4
    • Subjects with a CAPS-5 score of ≥ 30
    • If on psychotropic medication(s), on a stable dose during the course of treatment
  • This can include benzodiazepine use that is prescribed on an as needed basis. • If on psychotropic medication(s), patient agreement to maintain their current stable dose from point of study entry until the 2-month post-treatment assessment.

Exclusion Criteria:

  • Subject is pregnant.
  • Current enrollment in another device or drug study.
  • Enrollment in another drug or device study that is not at least 30 days past the final follow-up visit.
  • Currently undergoing cognitive behavioral therapy, or equivalent that is focused addressing PTSD including any evidenced based therapy that focuses on PTSD, including cognitive processing therapy, EMDR, prolonged exposure therapy, Virtual reality therapy, during trial and 2 month follow up. Cognitive therapy must be discontinued 1 month prior to enrolling in this study.
  • Severe suicidality, in the judgment of the interviewer and taking the CHART assessment into account
  • Psychotic disorder diagnosis, including schizophrenia and schizoaffective disorder
  • Presence of uncontrolled bipolar disorder as described below -

    • The subject has experienced a manic episode in the past 6 months and is not considered under control by reviewer
    • Bipolar disorder is considered the primary diagnosis for the subject, in the interviewer's opinion.
  • No Alcohol, drug use disorder that requires medical treatment . If stable under medical supervision treatment for drug/alcohol use, then OK
  • Cardiovascular or pulmonary disease, such as COPD.

    • Score of ≥ 10 on the COPD assessment
    • EtCO2 of ≥ 48 mmHg at first treatment visit
  • Epilepsy or seizures
  • Inability to understand or comply with study procedures.
  • The investigator feels that for any reason the subject is not eligible to participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christy Cowley, MPH 408-857-2083 christy@pahealthsciences.com
Contact: Debra Reisenthel debra@pahealthsciences.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03039231
Other Study ID Numbers  ICMJE P-16-FS02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Palo Alto Health Sciences, Inc.
Study Sponsor  ICMJE Palo Alto Health Sciences, Inc.
Collaborators  ICMJE VA Palo Alto Health Care System
Investigators  ICMJE
Principal Investigator: Michael J Ostacher, MD VA Palo Alto Health Care System
PRS Account Palo Alto Health Sciences, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP