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Freespira Breathing System for Anxiety and Panic Disorders in Children and Teens

This study is testing the Freespira Breathing System, a drug-free device, to see if it can help children and teenagers aged 9 to 17 with anxiety and panic disorders. The system is already approved for adults, but this study will see if it works for younger people. You might be able to join if you have a diagnosis of an anxiety disorder and a certain score on an anxiety questionnaire (SCARED score ≥ 25). If you are on medication, your dose must be stable for at least a month. The study will measure how well the Freespira system works by looking at changes in your SCARED score after 8 weeks. The study is currently unclear about its recruitment status and plans to enroll 73 participants.

Study design
This is an interventional study where participants will be randomly assigned to either receive the Freespira Breathing System immediately or after an 8-week baseline period. It plans to enroll 73 participants.
What's involved
Participants will use the Freespira Breathing System over an 8-week period. The primary outcome will be measured at 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 8 weeks, as this is when the primary outcome is measured.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02998502

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

Not Yet Recruiting
NAAges 9–17InterventionalTreatment
Johns Hopkins University
~73 participants
Updated 2026-03-09 on ClinicalTrials.gov
What's tested:Freespira Breathing System

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Screen for Child Anxiety Related Disorders (SCARED) scale score
Measured over 8-weeks

Conditions

Anxiety
Panic Disorder

Explore related trials

AnxietyObsessive Compulsive DisorderPanic Disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Marco Grados, M.D., M.P.H. · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Marco A Grados, M.D., M.P.H.
[email protected]
443-287-2292
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Screen for Child Anxiety Related Disorders (SCARED) scale score8-weeks

    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.