Using the Canary Breathing System for Panic Disorder Patients

NCT01955954 | Completed Results

• 1 other identifier: PAHS 1-001-13
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 4

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.

Conditions

Panic Disorder

Keywords

carbon dioxide monitoring; panic disorder; biofeedback; breathing training; Primary diagnosis; panic attacks

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  Measured post-treatment (week-5)

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

  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

Study Arms (1)

Canary Breathing System

EXPERIMENTAL

Treatment with Canary Breathing System

Device: Canary Breathing System

Interventions

Canary Breathing System DEVICE

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

Canary Breathing System

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto Health Sciences, Inc.: lead

Study Sites (4)

San Francisco Bay Area Center for Cognitive Therapy

Oakland, California, 94618, United States

Location

Institute of Living

Hartford, Connecticut, 06106, United States

Location

Alexian Brothers Center for Anxiety and OCD

Hoffman Estates, Illinois, 60169, United States

Location

Kansas City Center for Anxiety Treatment, P.A.

Overland Park, Kansas, 66212, United States

Location

Related 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/s10484-017-9354-4.

  PMID: 28194546 RESULT

Related Links

• Study Results

MeSH Terms

Conditions

Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Debra Reisenthel
• Organization: Palo Alto Health Sciences, Inc

debra@pahealthsciences.com

9255948404

Study Officials

• David Tolin, PhD

  Institute of Living, Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 6, 2018
• Results First Posted: February 6, 2018

Record last verified: 2018-01

Locations

US (4)