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Using the Canary Breathing System for Panic Disorder Patients

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ClinicalTrials.gov Identifier: NCT01955954
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Palo Alto Health Sciences, Inc.

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

Condition or disease Intervention/treatment Phase
Panic Disorder Device: Canary Breathing System Not Applicable

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  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Canary Breathing System for Treating the Symptoms of Panic Disorder
Study Start Date : September 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder
U.S. FDA Resources

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955954


Locations
United States, California
San Francisco Bay Area Center for Cognitive Therapy
Oakland, California, United States, 94618
United States, Connecticut
Institute of Living
Hartford, Connecticut, United States, 06106
United States, Illinois
Alexian Brothers Center for Anxiety and OCD
Hoffman Estates, Illinois, United States, 60169
United States, Kansas
Kansas City Center for Anxiety Treatment, P.A.
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Palo Alto Health Sciences, Inc.
Investigators
Principal Investigator: David Tolin, PhD Institute of Living, Hartford Hospital

Additional Information:
Publications of Results:
Responsible Party: Palo Alto Health Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01955954     History of Changes
Other Study ID Numbers: PAHS 1-001-13
First Posted: October 8, 2013    Key Record Dates
Results First Posted: February 6, 2018
Last Update Posted: February 6, 2018
Last Verified: January 2018

Keywords provided by Palo Alto Health Sciences, Inc.:
carbon dioxide monitoring
panic disorder
biofeedback
breathing training
Primary diagnosis
panic attacks

Additional relevant MeSH terms:
Disease
Respiratory Aspiration
Panic Disorder
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Anxiety Disorders
Mental Disorders