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

NCT ID: NCT03039231

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2019-08-25

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Freespira Breathing System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Palo Alto Health Care System

FED

Sponsor Role: collaborator

Palo Alto Health Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Ostacher, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Locations

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

Palo Alto, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34468913 (View on PubMed)

Related Links

http://www.freespira.com

For more information about the Freespira Breathing System click on link

Other Identifiers

P-16-FS02

Identifier Type: -

Identifier Source: org_study_id