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

• ClinicalTrials.gov Identifier: NCT03039231
• Recruitment Status: Completed
• First Posted: February 1, 2017
• Last Update Posted: March 25, 2020
• Sponsor: Palo Alto Health Sciences, Inc.
• Collaborator: VA Palo Alto Health Care System
• Information provided by (Responsible Party): Palo Alto Health Sciences, Inc.

Study Description

Brief Summary:

This study will test the efficacy of the Freespira Breathing System in adults with post traumatic stress disorder (PTSD).

Condition or disease	Intervention/treatment	Phase
Stress Disorders, Post-Traumatic	Device: Freespira Breathing System	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Investigation of the Freespira Breathing System in the Treatment of PTSD
• Actual Study Start Date: February 1, 2017
• Actual Primary Completion Date: April 24, 2019
• Actual Study Completion Date: August 25, 2019

Arms and Interventions

Arm

Intervention/treatment

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.

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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.
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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine/Palo Alto Veterans Institute for Research

Palo Alto, California, United States, 94304

Sponsors and Collaborators

Palo Alto Health Sciences, Inc.

VA Palo Alto Health Care System

Investigators

• Principal Investigator: Michael J Ostacher, MD; VA Palo Alto Health Care System

More Information

Additional Information:

For more information about the Freespira Breathing System click on link 

• Responsible Party: Palo Alto Health Sciences, Inc.
• ClinicalTrials.gov Identifier: NCT03039231
• Other Study ID Numbers: P-16-FS02
• First Posted: February 1, 2017
• Last Update Posted: March 25, 2020
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Palo Alto Health Sciences, Inc.:

PTSD

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders