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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canary Breathing System | Experimental | Treatment with Canary Breathing System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canary Breathing System | Device | The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Tolin, PhD | Institute of Living, Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Bay Area Center for Cognitive Therapy | Oakland | California | 94618 | United States | ||
| Institute of Living |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28194546 | Result | 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. |
| Label | URL |
|---|---|
| Study Results | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Canary Breathing System | Treatment with Canary Breathing System Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Canary Breathing System | Treatment with Canary Breathing System Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Measured at 2 months post-treatment. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Canary Breathing System | Treatment with Canary Breathing System Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debra Reisenthel | Palo Alto Health Sciences, Inc | 9255948404 | debra@pahealthsciences.com |
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| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Measured post-treatment (week-5) |
| 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. |
| Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week | Measured post-treatment (week-5) |
| Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week | Measured at 2 months post-treatment |
| Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week | Measured at 12 months post-treatment |
| Hartford |
| Connecticut |
| 06106 |
| United States |
| Alexian Brothers Center for Anxiety and OCD | Hoffman Estates | Illinois | 60169 | United States |
| Kansas City Center for Anxiety Treatment, P.A. | Overland Park | Kansas | 66212 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Measured at 12 months post-treatment. |
|
|
|
| Secondary | Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week | Posted | Count of Participants | Participants | Measured post-treatment (week-5) |
|
|
|
| Secondary | Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week | Posted | Count of Participants | Participants | Measured at 2 months post-treatment |
|
|
|
| Secondary | Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week | Posted | Count of Participants | Participants | Measured at 12 months post-treatment |
|
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| 1 |
| 69 |
| Lightheadedness | General disorders | Systematic Assessment |
|
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