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Using the Canary Breathing System for Panic Disorder Patients

Primary Purpose

Panic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Canary Breathing System
Sponsored by
Palo Alto Health Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring carbon dioxide monitoring, panic disorder, biofeedback, breathing training, Primary diagnosis, panic attacks

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco Bay Area Center for Cognitive Therapy
  • Institute of Living
  • Alexian Brothers Center for Anxiety and OCD
  • Kansas City Center for Anxiety Treatment, P.A.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Canary Breathing System

Arm Description

Treatment with Canary Breathing System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2013
Last Updated
January 10, 2018
Sponsor
Palo Alto Health Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01955954
Brief Title
Using the Canary Breathing System for Panic Disorder Patients
Official Title
Investigation of the Canary Breathing System for Treating the Symptoms of Panic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palo Alto Health Sciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
carbon dioxide monitoring, panic disorder, biofeedback, breathing training, Primary diagnosis, panic attacks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canary Breathing System
Arm Type
Experimental
Arm Description
Treatment with Canary Breathing System
Intervention Type
Device
Intervention Name(s)
Canary Breathing System
Intervention Description
The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns.
Primary Outcome Measure Information:
Title
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
Description
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.
Time Frame
Measured at 2 months post-treatment.
Secondary Outcome Measure Information:
Title
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
Description
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.
Time Frame
Measured post-treatment (week-5)
Title
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
Description
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.
Time Frame
Measured at 12 months post-treatment.
Title
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Time Frame
Measured post-treatment (week-5)
Title
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Time Frame
Measured at 2 months post-treatment
Title
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Time Frame
Measured at 12 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Tolin, PhD
Organizational Affiliation
Institute of Living, Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Bay Area Center for Cognitive Therapy
City
Oakland
State/Province
California
ZIP/Postal Code
94618
Country
United States
Facility Name
Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Alexian Brothers Center for Anxiety and OCD
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Kansas City Center for Anxiety Treatment, P.A.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28194546
Citation
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.
Results Reference
result
Links:
URL
https://link.springer.com/content/pdf/10.1007%2Fs10484-017-9354-4.pdf
Description
Study Results

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Using the Canary Breathing System for Panic Disorder Patients

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