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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT02998502
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Panic Disorder

Eligibility Criteria

Sex
ALL
Age
9 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Freespira Breathing System — DEVICE
    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.

Study Details

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

Key Dates

Start date
Aug 1, 2026
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
73 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Device Group
    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.
  • No Intervention: Control Group
    The device will be given to those in the control group after 8-week baseline period.

Primary Outcome Measure

Screen for Child Anxiety Related Disorders (SCARED) scale score [ Time Frame: 8-weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21218-

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By research site
Johns Hopkins University· Baltimore, MD

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