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

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.

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