Trial record 2 of 23 for:    canary

Using the Canary Breathing System for Panic Disorder Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Palo Alto Health Sciences, Inc.
Sponsor:
Information provided by (Responsible Party):
Palo Alto Health Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01955954
First received: September 30, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Panic Disorder
Device: Canary Breathing System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of the Canary Breathing System for Treating the Symptoms of Panic Disorder

Resource links provided by NLM:


Further study details as provided by Palo Alto Health Sciences, Inc.:

Primary Outcome Measures:
  • Score on the Panic Disorder Severity Scale [ Time Frame: Measured at 2 months past the last intervention. ] [ Designated as safety issue: No ]

Estimated Enrollment: 47
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canary Breathing System Device: Canary Breathing System
The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of normal breathing patterns.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955954

Contacts
Contact: Debra Reisenthel Debra@PAHealthSciences.com

Locations
United States, California
San Francisco Bay Area Center for Cognitive Therapy Recruiting
Oakland, California, United States, 94618
Contact: Nadya Tannous    510-652-4455 ext 6    canarystudy@sfbacct.com   
United States, Connecticut
Institute of Living Recruiting
Hartford, Connecticut, United States, 06106
Contact: Marla Genova, MA    860-545-7707    Marla.Genova@hhchealth.org   
United States, Illinois
Alexian Brothers Center for Anxiety and OCD Recruiting
Hoffman Estates, Illinois, United States, 60169
Contact: Mary Lee    847-230-3509      
United States, Kansas
Kansas City Center for Anxiety Treatment, P.A. Recruiting
Overland Park, Kansas, United States, 66212
Contact: Becky Selover, MA    913-956-6210    research@kcanxiety.com   
Sponsors and Collaborators
Palo Alto Health Sciences, Inc.
  More Information

No publications provided

Responsible Party: Palo Alto Health Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01955954     History of Changes
Other Study ID Numbers: PAHS 1-001-13
Study First Received: September 30, 2013
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Palo Alto Health Sciences, Inc.:
carbon dioxide monitoring
panic disorder
biofeedback
breathing training
Primary diagnosis

Additional relevant MeSH terms:
Respiratory Aspiration
Panic Disorder
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014