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

Investigation of the Freespira Breathing System in the Treatment of PTSD

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

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Device: Freespira Breathing System

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: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University School of Medicine/Palo Alto Veterans Institute for Research

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome of this study will be quantitative improvements using the Clinician Administered PTSD Scale (CAPS - 5).	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.	2 month and 6 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire (PHQ-9) Score	Change in condition (score) as recorded from baseline	2 month and 6 months post treatment
Change in 36-Item Short Form Survey (SF-36) Score	Change in condition (score) as recorded from baseline	2 month and 6 months post treatment
Change in Clinical Global Impression (CGC-S) Score	Change in condition (score) as recorded from baseline	2 month and 6 months post treatment
Change in Panic Disorder and Severity Scale (PDSS) Score	Proportion achieving a clinically significant 40% decrease, proportion achieving a remission score <= 5.	2 month and 6 months post treatment
Proportion achieving "Remission" by CAPS-5 Score	Remission is defined as 'Response' plus no longer meeting clinical symptom criteria and having a severity score of <25.	2 month and 6 months post treatment

Collaborators and Investigators

• Sponsor: Palo Alto Health Sciences, Inc.
• Collaborators: VA Palo Alto Health Care System
• Investigators: Principal Investigator: Michael J Ostacher, MD, VA Palo Alto Health Care System

Publications and helpful links

General Publications

• Ostacher MJ, Fischer E, Bowen ER, Lyu J, Robbins DJ, Suppes T. Investigation of a Capnometry Guided Respiratory Intervention in the Treatment of Posttraumatic Stress Disorder. Appl Psychophysiol Biofeedback. 2021 Dec;46(4):367-376. doi: 10.1007/s10484-021-09521-3.

Helpful Links

• For more information about the Freespira Breathing System click on link

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): August 25, 2019

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: PTSD
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: P-16-FS02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes