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

Primary Purpose

Stress Disorders, Post-Traumatic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Freespira Breathing System

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Freespira Breathing System (FBS)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Patient Health Questionnaire (PHQ-9) Score

Change in condition (score) as recorded from baseline

Change in 36-Item Short Form Survey (SF-36) Score

Change in condition (score) as recorded from baseline

Change in Clinical Global Impression (CGC-S) Score

Change in condition (score) as recorded from baseline

Change in Panic Disorder and Severity Scale (PDSS) Score

Proportion achieving a clinically significant 40% decrease, proportion achieving a remission score <= 5.

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.

Full Information

NCT ID

NCT03039231

First Posted

January 25, 2017

Last Updated

March 23, 2020

Sponsor

Palo Alto Health Sciences, Inc.

Collaborators

VA Palo Alto Health Care System

1. Study Identification

Unique Protocol Identification Number

NCT03039231

Brief Title

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

Official Title

Investigation of the Freespira Breathing System in the Treatment of PTSD

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

April 24, 2019 (Actual)

Study Completion Date

August 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Palo Alto Health Sciences, Inc.

Collaborators

VA Palo Alto Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Disorders, Post-Traumatic

Keywords

PTSD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Freespira Breathing System (FBS)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Freespira Breathing System

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

2 month and 6 months post treatment

Secondary Outcome Measure Information:

Title

Change in Patient Health Questionnaire (PHQ-9) Score

Description

Change in condition (score) as recorded from baseline

Time Frame

2 month and 6 months post treatment

Title

Change in 36-Item Short Form Survey (SF-36) Score

Description

Change in condition (score) as recorded from baseline

Time Frame

2 month and 6 months post treatment

Title

Change in Clinical Global Impression (CGC-S) Score

Description

Change in condition (score) as recorded from baseline

Time Frame

2 month and 6 months post treatment

Title

Change in Panic Disorder and Severity Scale (PDSS) Score

Description

Proportion achieving a clinically significant 40% decrease, proportion achieving a remission score <= 5.

Time Frame

2 month and 6 months post treatment

Title

Proportion achieving "Remission" by CAPS-5 Score

Description

Remission is defined as 'Response' plus no longer meeting clinical symptom criteria and having a severity score of <25.

Time Frame

2 month and 6 months post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael J Ostacher, MD

Organizational Affiliation

VA Palo Alto Health Care System

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34468913

Citation

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.

Results Reference

derived

Links:

URL

http://www.freespira.com

Description

For more information about the Freespira Breathing System click on link

Learn more about this trial

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

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