Stress Disorders, Post-TraumaticNCT03039231
Investigation of the Freespira Breathing System in the Treatment of Post Traumatic Stress Disorder (PTSD)
A study testing Freespira Breathing System in people with Stress Disorders, Post-Traumatic, run by Palo Alto Health Sciences, Inc. at 1 site in United States.
Trial summary
This study will test the efficacy of the Freespira Breathing System in adults with post traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Freespira Breathing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 25 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine/Palo Alto Veterans Institute for Research
Palo Alto, California, 94304
About this study
Official title: 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).
Read the 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
- Being tested
- Freespira Breathing System
- Keywords
- PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freespira Breathing SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Freespira Breathing System (FBS) | Experimental | 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. Receives: Device: Freespira Breathing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 month and 6 months post treatment
Secondary outcomes (5)
Change in Patient Health Questionnaire (PHQ-9) Score
Change in condition (score) as recorded from baseline
Measured: 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
Measured: 2 month and 6 months post treatment
Change in Clinical Global Impression (CGC-S) Score
Change in condition (score) as recorded from baseline
Measured: 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.
Measured: 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.
Measured: 2 month and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion24 Apr 2019
- Study completion25 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Health Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Palo Alto Health Care System
- Responsible party
- Sponsor
- Investigators
- Michael J Ostacher, MD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039231
- Sponsor's protocol ID
- P-16-FS02
- Status last verified
- Apr 2018
- First submitted
- 25 Jan 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 34468913
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Freespira Breathing System in the Treatment of PTSD
- ClinicalTrials.gov ID
- NCT03039231
- Acronym / sponsor ID
- P-16-FS02
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Palo Alto Health Sciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- VA Palo Alto Health Care System
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Freespira Breathing System (FBS) | Experimental | Device: Freespira Breathing SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freespira Breathing SystemFollowing 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. | Device | Freespira Breathing System (FBS) |
Primary outcome
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.
5 secondary outcomes
Change in Patient Health Questionnaire (PHQ-9) Score
Time frame: 2 month and 6 months post treatment
Change in 36-Item Short Form Survey (SF-36) Score
Time frame: 2 month and 6 months post treatment
Change in Clinical Global Impression (CGC-S) Score
Time frame: 2 month and 6 months post treatment
Change in Panic Disorder and Severity Scale (PDSS) Score
Time frame: 2 month and 6 months post treatment
Proportion achieving "Remission" by CAPS-5 Score
Time frame: 2 month and 6 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 34468913Ostacher 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.
- For more information about the Freespira Breathing System click on linkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Ostacher, MD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freespira Breathing System in people with Stress Disorders, Post-Traumatic, run by Palo Alto Health Sciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03039231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.