NCT02998502

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

Efficacy of a Biofeedback Breathing System for Anxiety and Panic Disorders

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Anxiety
• Panic Disorder

Interventions

Type	Name	Description
DEVICE	Freespira Breathing System	Over an 8-week period the efficacy of the FBS system in youth will be tested, with those in the randomized active device group. The control group will not receive the device until completion of the 8 week baseline.

Timeline

• Start date: 2026-08-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2016-12-20
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States