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

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Device: Freespira Breathing System

• Registration Number: NCT03039231
• Lead Sponsor: Palo Alto Health Sciences, Inc.

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 Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-30
• Study Start: 2017-02-01
• Study First Posted: 2017-02-01
• Status Verified: 2018-04
• Primary Completion: 2019-04-24
• Study Completion: 2019-08-25
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Freespira Breathing System (FBS)	Freespira Breathing System	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.

Primary Outcome Measures

Name	Time	Method
Primary outcome of this study will be quantitative improvements using the Clinician Administered PTSD Scale (CAPS - 5).	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

Name	Time	Method
Change in Patient Health Questionnaire (PHQ-9) Score	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	2 month and 6 months post treatment	Change in condition (score) as recorded from baseline
Change in Clinical Global Impression (CGC-S) Score	2 month and 6 months post treatment	Change in condition (score) as recorded from baseline
Change in Panic Disorder and Severity Scale (PDSS) Score	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	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.

Trial Locations

Locations (1)

Stanford University School of Medicine/Palo Alto Veterans Institute for Research; 🇺🇸 Palo Alto, California, United States