Using the Canary Breathing System for Panic Disorder Patients

Panic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955954
• Other study ID #: PAHS 1-001-13
• Status: Completed
• Phase: N/A
• First received: September 30, 2013
• Last updated: January 10, 2018
• Start date: September 2013
• Est. completion date: May 2016

Study information

• Verified date: January 2018
• Source: Palo Alto Health Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Panic Disorder
• Respiratory Aspiration

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Palo Alto Health Sciences, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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.
Secondary	Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week		Measured post-treatment (week-5)
Secondary	Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week		Measured at 2 months post-treatment
Secondary	Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week		Measured at 12 months post-treatment

External Links

•   Study Results