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Completed

NCT Number: NCT01955954

Using the Canary Breathing System for Panic Disorder Patients

The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS) in treating the symptoms of panic disorder.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Bay Area Center for Cognitive Therapy, Oakland, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canary Breathing System

Device

The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)

    Time frame: Measured post-treatment (week-5)

    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.

  2. Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)

    Time frame: Measured at 12 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.

  3. Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week

    Time frame: Measured post-treatment (week-5)

  4. Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week

    Time frame: Measured at 2 months post-treatment

  5. Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week

    Time frame: Measured at 12 months post-treatment

Sponsors and collaborators

Lead sponsor

Palo Alto Health Sciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2013
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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