Using the Canary Breathing System for Panic Disorder Patients

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder
• Intervention / Treatment: Device: Canary Breathing System

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94618
      • San Francisco Bay Area Center for Cognitive Therapy
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Institute of Living
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Alexian Brothers Center for Anxiety and OCD
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Kansas City Center for Anxiety Treatment, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Palo Alto Health Sciences, Inc.
• Investigators: Principal Investigator: David Tolin, PhD, Institute of Living, Hartford Hospital

Publications and helpful links

General 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.

Helpful Links

• Study Results

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: biofeedback; panic disorder; Primary diagnosis; carbon dioxide monitoring; panic attacks; breathing training
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Anxiety Disorders; Disease; Respiratory Aspiration; Panic Disorder
• Other Study ID Numbers: PAHS 1-001-13