The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens

Johns Hopkins University

Status: Begins enrollment this month

Conditions: Panic Disorder; Anxiety

Treatments: Device: Freespira Breathing System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02998502

IRB00097094

Details and patient eligibility

About

This study will test the efficiency of the Freespira Breathing System in youth.

Full description

The Freespira Breathing System (FBS; www.freespira.com) developed by Palo Alto Health Sciences, Inc, is a portable home device , and has been employed in breathing biofeedback in adults with panic disorder (PD). The FBS has now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for cognitive behavioral therapy (CBT) or lower acceptability for long-term medication use for adolescent PD.

In this pilot intervention study, the efficacy of the FBS system in youth will be tested. In children adolescents, PD itself is less common than in adults, but when present, PD is commonly associated with and/or preceded by other anxiety conditions, including generalized anxiety disorder (GAD), social phobia (SoP) and separation anxiety (SAD). Thus, in children and adolescents, the breathing biofeedback intervention for panic, should include other anxiety disorders.

Enrollment: 73 estimated patients

Sex: All

Ages: 9 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SCARED score ≥ 25 + prior clinical diagnosis of an anxiety disorder
• Participants must be 9-17 years of age
• If on psychotropic medication(s), participant must be on a stable dose for at least one month prior to study enrollment

Exclusion criteria

• Anxiety has occurred exclusively during a major depressive episode, psychiatric illness, dementia, intellectual disability, or brain disease
• Currently enrolled in another device or drug study or less than 30 days has elapsed since participation in such a study
• Currently undergoing breathing biofeedback elsewhere
• Demonstrate evidence of severe suicidal ideation or psychosis
• There is an active condition of asthma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Device Group

Experimental group

Description:

The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device used for breathing biofeedback in adults with PD. FBS has now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for CBT or lower acceptability for long-term medication use for adolescent PD. In this pilot intervention study, the efficacy of the FBS system in youth will be tested.

Treatment:

Device: Freespira Breathing System

Control Group

No Intervention group

Description:

The device will be given to those in the control group after 8-week baseline period.