Using the Canary Breathing System for Panic Disorder Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigation of the Canary Breathing System for Treating the Symptoms of Panic Disorder

Conditions
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Panic Disorder

Intervention / Treatment
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* Device: Canary Breathing System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canary Breathing System<br>Treatment with Canary Breathing System | Device: Canary Breathing System<br>* The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 at 2 months post-treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 at 12 months post-treatment. | 
| Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week |  | Measured post-treatment (week-5) | 
| Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week |  | Measured at 2 months post-treatment | 
| Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week |  | Measured at 12 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbon dioxide monitoring, panic disorder, biofeedback, breathing training, Primary diagnosis, panic attacks