Using the Canary Breathing System for Panic Disorder Patients

Palo Alto Health Sciences

Status: Completed

Conditions: Panic Disorder

Treatments: Device: Canary Breathing System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01955954

PAHS 1-001-13

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Canary Breathing System

Experimental group

Description:

Treatment with Canary Breathing System

Treatment:

Device: Canary Breathing System