Panic DisorderNCT01955954
Using the Canary Breathing System for Panic Disorder Patients
A study testing Canary Breathing System in people with Panic Disorder, run by Palo Alto Health Sciences, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS) in treating the symptoms of panic disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Canary Breathing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2013to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary diagnosis of Panic Disorder
- Subjects between 18 and 60 years of age (inclusive on day of enrollment)
- Subjects with a Clinician's Global Impression of > or = to 4.
- If on psychotropic medication, on a stable dose for a minimum of 3 months prior to enrollment
- If on psychotropic medication, an agreement to stay on their stable dose from study entry until the 2-month follow-up.
Who cannot join
- Pregnancy
- Current enrollment in another drug or device study
- Current enrollment in another drug or device study that is not at least 30 days past the final follow-up
- Currently undergoing cognitive behavioral therapy (or equivalent)
- Refractory to either a breathing training program or cognitive behavioral therapy (or equivalent) in the 3 months prior to enrollment
- Evidence of organic mental disorder
Show all 13Show fewer
- Severe suicidality
- Presence of any psychotic disorder
- Bipolar disorder that is present for < 5 years; a major depressive, manic or hypomanic episode in the last 12 months; failure to take and maintain a stable dose of medication in treatment of bipolar disorder in the last 12 months
- Current alcohol or drug dependence
- Cardiovascular or pulmonary disease
- Epilepsy or seizures
- Undergoing additional psychologic treatment at any point from study enrollment to 2-month follow-up to treat panic disorder
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Institute of Living
Hartford, Connecticut, 06106
Alexian Brothers Center for Anxiety and OCD
Hoffman Estates, Illinois, 60169
San Francisco Bay Area Center for Cognitive Therapy
Oakland, California, 94618
Kansas City Center for Anxiety Treatment, P.A.
Overland Park, Kansas, 66212
About this study
Official title: Investigation of the Canary Breathing System for Treating the Symptoms of Panic Disorder
The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS) in treating the symptoms of panic disorder.
Read the detailed description
Panic disorder (PD) is associated with hyperventilation. The efficacy of a brief respiratory feedback program for PD has been previously established. The aim of the present study was to expand these results by testing a similar program with more clinically representative patients and settings. The intervention is delivered via home use following initial training by a clinician and provides remote monitoring of client adherence and progress by the clinician. Outcomes were assessed post-treatment and at 2- and 12-month follow-up.
- Conditions
- Panic Disorder
- Being tested
- Canary Breathing System
- Keywords
- carbon dioxide monitoring, panic disorder, biofeedback, breathing training, Primary diagnosis, panic attacks
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canary Breathing SystemDevice
The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns.
| Study group | Role | What they receive |
|---|---|---|
| Canary Breathing System | Experimental | Treatment with Canary Breathing System Receives: Device: Canary Breathing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms.
A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as "Response" in this study.
Measured: Measured at 2 months post-treatment.
Secondary outcomes (5)
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms.
A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as "Response" in this study.
Measured: Measured post-treatment (week-5)
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms.
A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as "Response" in this study.
Measured: Measured at 12 months post-treatment.
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Measured: Measured post-treatment (week-5)
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Measured: Measured at 2 months post-treatment
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Measured: Measured at 12 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 posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Health Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Tolin, PhD, Principal investigator, Institute of Living, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955954
- Sponsor's protocol ID
- PAHS 1-001-13
- Status last verified
- Jan 2018
- First submitted
- 30 Sep 2013
- Last updated
- 6 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tolin DF, McGrath PB, Hale LR, Weiner DN, Gueorguieva R. A Multisite Benchmarking Trial of Capnometry Guided Respiratory Intervention for Panic Disorder in Naturalistic Treatment Settings. Appl Psychophysiol Biofeedback. 2017 Mar;42(1):51-58. doi: 10.1007/s10484-017-9354-4.
PubMed 28194546
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Canary Breathing System for Treating the Symptoms of Panic Disorder
- ClinicalTrials.gov ID
- NCT01955954
- Acronym / sponsor ID
- PAHS 1-001-13
- Conditions
- Panic Disorder
- Keywords
- carbon dioxide monitoring, panic disorder, biofeedback, breathing training, Primary diagnosis, panic attacks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Palo Alto Health Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 6 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS) in treating the symptoms of panic disorder.
Detailed description
Panic disorder (PD) is associated with hyperventilation. The efficacy of a brief respiratory feedback program for PD has been previously established. The aim of the present study was to expand these results by testing a similar program with more clinically representative patients and settings. The intervention is delivered via home use following initial training by a clinician and provides remote monitoring of client adherence and progress by the clinician. Outcomes were assessed post-treatment and at 2- and 12-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Canary Breathing System | Experimental | Device: Canary Breathing SystemTreatment with Canary Breathing System |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primary diagnosis of Panic Disorder
- Subjects between 18 and 60 years of age (inclusive on day of enrollment)
- Subjects with a Clinician's Global Impression of > or = to 4.
- If on psychotropic medication, on a stable dose for a minimum of 3 months prior to enrollment
- If on psychotropic medication, an agreement to stay on their stable dose from study entry until the 2-month follow-up.
Key exclusion criteria (13 listed)
- Pregnancy
- Current enrollment in another drug or device study
- Current enrollment in another drug or device study that is not at least 30 days past the final follow-up
- Currently undergoing cognitive behavioral therapy (or equivalent)
- Refractory to either a breathing training program or cognitive behavioral therapy (or equivalent) in the 3 months prior to enrollment
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 |
|---|---|---|
| Canary Breathing SystemThe Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns. | Device | Canary Breathing System |
Primary outcome
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
Time frame: Measured at 2 months post-treatment.
The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms. A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as "Response" in this study.
5 secondary outcomes
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
Time frame: Measured post-treatment (week-5)
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
Time frame: Measured at 12 months post-treatment.
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Time frame: Measured post-treatment (week-5)
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Time frame: Measured at 2 months post-treatment
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Time frame: Measured at 12 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28194546Tolin DF, McGrath PB, Hale LR, Weiner DN, Gueorguieva R. A Multisite Benchmarking Trial of Capnometry Guided Respiratory Intervention for Panic Disorder in Naturalistic Treatment Settings. Appl Psychophysiol Biofeedback. 2017 Mar;42(1):51-58. doi: 10.1007/s10484-017-9354-4.
- Study ResultsLink provided by the sponsor.
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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.
David Tolin, PhD principal investigator
Institute of Living, Hartford Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canary Breathing System in people with Panic Disorder, run by Palo Alto Health Sciences, Inc. at 4 sites 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 5 inclusion and 13 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 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 6 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response) (time frame: Measured at 2 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 NCT01955954, 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 6 Feb 2018.