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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01955954
Other study ID # PAHS 1-001-13
Secondary ID
Status Completed
Phase N/A
First received September 30, 2013
Last updated January 10, 2018
Start date September 2013
Est. completion date May 2016

Study information

Verified date January 2018
Source Palo Alto Health Sciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Institute of Living Hartford Connecticut
United States Alexian Brothers Center for Anxiety and OCD Hoffman Estates Illinois
United States San Francisco Bay Area Center for Cognitive Therapy Oakland California
United States Kansas City Center for Anxiety Treatment, P.A. Overland Park Kansas

Sponsors (1)

Lead Sponsor Collaborator
Palo Alto Health Sciences, Inc.

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 post-treatment (week-5)
Secondary 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 12 months post-treatment.
Secondary Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week Measured post-treatment (week-5)
Secondary Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week Measured at 2 months post-treatment
Secondary Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week Measured at 12 months post-treatment
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