Clinical trial NCT01955954: 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
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Keywords: carbon dioxide monitoring
panic disorder
biofeedback
breathing training
Primary diagnosis
panic attacks
Lead sponsor: Palo Alto Health Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
timeFrame: Measured at 2 months post-treatment.
Secondary outcomes:
measure: Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
timeFrame: Measured post-treatment (week-5)
measure: Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
timeFrame: Measured at 12 months post-treatment.
measure: Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
timeFrame: Measured post-treatment (week-5)
measure: Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
timeFrame: Measured at 2 months post-treatment
measure: Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
timeFrame: Measured at 12 months post-treatment
Other outcomes:
Locations:
city: Oakland
country: United States
facility: San Francisco Bay Area Center for Cognitive Therapy
state: California
city: Hartford
country: United States
facility: Institute of Living
state: Connecticut
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Anxiety and OCD
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Center for Anxiety Treatment, P.A.
state: Kansas
Study officials:
affiliation: Institute of Living, Hartford Hospital
name: David Tolin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.