Trial Outcomes & Findings for Using the Canary Breathing System for Panic Disorder Patients (NCT NCT01955954)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

Measured at 2 months post-treatment.

Results posted on

2018-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	69
Overall Study Received Treatment	66
Overall Study Completed Treatment	53
Overall Study Completed Post-treatment Assessement	48
Overall Study Completed 2-month Assessment	46
Overall Study Completed 6-month Assessement	42
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using the Canary Breathing System for Panic Disorder Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Canary Breathing System n=69 Participants 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.
Age, Continuous	36.6 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at 2 months post-treatment.

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.

Outcome measures

Outcome measures
Measure	Canary Breathing System n=46 Participants 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.
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)	33 Participants

SECONDARY outcome

Timeframe: Measured post-treatment (week-5)

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.

Outcome measures

Outcome measures
Measure	Canary Breathing System n=48 Participants 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.
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)	41 Participants

SECONDARY outcome

Timeframe: Measured at 12 months post-treatment.

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.

Outcome measures

Outcome measures
Measure	Canary Breathing System n=33 Participants 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.
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)	27 Participants

SECONDARY outcome

Timeframe: Measured post-treatment (week-5)

Outcome measures

Outcome measures
Measure	Canary Breathing System n=48 Participants 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.
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week	34 Participants

SECONDARY outcome

Timeframe: Measured at 2 months post-treatment

Outcome measures

Outcome measures
Measure	Canary Breathing System n=46 Participants 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.
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week	33 Participants

SECONDARY outcome

Timeframe: Measured at 12 months post-treatment

Outcome measures

Outcome measures
Measure	Canary Breathing System n=33 Participants 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.
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week	26 Participants

Adverse Events

Canary Breathing System

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Canary Breathing System n=69 participants at risk 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.
General disorders Dizziness	1.4% 1/69 • Number of events 1
General disorders Lightheadedness	1.4% 1/69 • Number of events 1

Additional Information

Debra Reisenthel

Palo Alto Health Sciences, Inc

Phone: 9255948404

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place