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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Investigation of the Freespira Breathing System in the Treatment of PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039231
• Other study ID #: P-16-FS02
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: August 25, 2019

Study information

• Verified date: April 2018
• Source: Palo Alto Health Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 25, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine/Palo Alto Veterans Institute for Research	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Health Sciences, Inc.	VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Patient Health Questionnaire (PHQ-9) Score	Change in condition (score) as recorded from baseline	2 month and 6 months post treatment
Secondary	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
Secondary	Change in Clinical Global Impression (CGC-S) Score	Change in condition (score) as recorded from baseline	2 month and 6 months post treatment
Secondary	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
Secondary	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

External Links

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