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

NCT02998502 | Not Yet Recruiting

• 1 other identifier: IRB00097094
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety; Panic Disorder

Keywords

Obsessive Compulsive Disorder (OCD); Anxiety; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Screen for Child Anxiety Related Disorders (SCARED) scale score

  The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.

  8-weeks

Secondary Outcomes (19)

• SCARED anxiety scale score

  Baseline

• SCARED anxiety scale score

  Week 4 Follow Up

• SCARED anxiety scale score

  Week 8 Follow Up

• SCARED anxiety scale score

  6-month Follow Up

• SCARED anxiety scale score

  12-month Follow Up

Other Outcomes (14)

• Child Sheehan Disability Scale (CSDS)

  Baseline

• Child Sheehan Disability Scale (CSDS)

  Week 4 Follow Up

• Child Sheehan Disability Scale (CSDS)

  Week 8 Follow Up

Study Arms (2)

Device Group

EXPERIMENTAL

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.

Device: Freespira Breathing System

Control Group

NO INTERVENTION

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

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.

Device Group

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Palo Alto Health Sciences, Inc.: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Panic Disorder; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Marco Grados, M.D., M.P.H.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco A Grados, M.D., M.P.H.

CONTACT

443-287-2292; mgrados1@jhmi.edu

Mary Chen

CONTACT

443-390-8494; mchen117@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 20, 2016
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)