Investigation of the Freespira Breathing System in the Treatment of Post Traumatic Stress Disorder (PTSD)
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|ClinicalTrials.gov Identifier: NCT03039231|
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic||Device: Freespira Breathing System||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of the Freespira Breathing System in the Treatment of PTSD|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||October 31, 2019|
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.
- Primary outcome of this study will be quantitative improvements using the Clinician Administered PTSD Scale (CAPS - 5). [ Time Frame: 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.
- Change in Patient Health Questionnaire (PHQ-9) Score [ Time Frame: 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 [ Time Frame: 2 month and 6 months post treatment ]Change in condition (score) as recorded from baseline
- Change in Clinical Global Impression (CGC-S) Score [ Time Frame: 2 month and 6 months post treatment ]Change in condition (score) as recorded from baseline
- Change in Panic Disorder and Severity Scale (PDSS) Score [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039231
|Contact: Christy Cowley, MPHemail@example.com|
|Contact: Debra Reisenthelfirstname.lastname@example.org|
|United States, California|
|Stanford University School of Medicine/Palo Alto Veterans Institute for Research||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Grace Fisher, BS 650-493-5000 ext 67570 email@example.com|
|Contact: Denishia Robbins, MS 650-493-5000 ext 63277 firstname.lastname@example.org|
|Principal Investigator:||Michael J Ostacher, MD||VA Palo Alto Health Care System|