Using the Canary Breathing System for Panic Disorder Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Panic Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Canary Breathing System

Treatment with Canary Breathing System

Group Type EXPERIMENTAL

Canary Breathing System

Intervention Type DEVICE

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

Interventions

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Canary Breathing System

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No