Freespira Breathing System for Anxiety

Overseen By Mary Chen

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Major depressive episode, Psychosis, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the Freespira Breathing System in helping young people with anxiety. The Freespira device, a portable tool providing breathing biofeedback, is already used by adults with panic disorder. The trial will compare children using the device to those who are not, to determine if it reduces anxiety over time. It is suitable for children aged 9 to 17 who have an anxiety diagnosis and have been stable on any medication for at least a month. As an unphased trial, this study offers participants a unique opportunity to contribute to understanding how this device can benefit young people with anxiety.

Will I have to stop taking my current medications?

If you are taking psychotropic medications (drugs that affect your mood or mind), you can continue them as long as your dose has been stable for at least one month before joining the study.

What prior data suggests that the Freespira Breathing System is safe for youth?

Research has shown that the Freespira Breathing System is generally safe to use. The FDA has approved it for treating panic disorder and post-traumatic stress disorder (PTSD) in adults. Studies indicate that it improves symptoms in these conditions without causing serious side effects. The device is also approved for teenagers aged 13–17, indicating it has been reviewed and found safe for this age group. Although the Freespira system hasn't been specifically tested in younger children, its use in both adults and teens suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Freespira Breathing System for anxiety because it offers a unique, non-drug approach to treating panic disorder (PD). Unlike standard treatments like Cognitive Behavioral Therapy (CBT) or long-term medication use, Freespira is a portable home device that uses breathing biofeedback, potentially making it more convenient and appealing, especially for younger users. This system allows users to manage their symptoms anywhere, without the need for frequent therapy sessions or medication adherence, providing an innovative and accessible option for those with PD.

What evidence suggests that the Freespira Breathing System is effective for anxiety in youth?

Research has shown that the Freespira Breathing System can greatly reduce symptoms for many people with panic disorder. In one large study, 93% of participants experienced a major improvement, with symptoms decreasing by at least 40%. Another study found that over 80% of participants had a significant reduction or even elimination of their symptoms. Most users also reported being free of panic attacks after using Freespira. While these results are promising for adults with panic disorder, this trial will test the system's effectiveness in young people with anxiety, as it has not yet been tested in this population. ^{1 2 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for children and teens aged 9-17 who have been clinically diagnosed with an anxiety disorder, as indicated by a SCARED score of 25 or higher. Participants must be on a stable dose of any psychotropic medications for at least one month before joining the study.

Inclusion Criteria

I have a high anxiety score and a diagnosis of an anxiety disorder.

I am between 9 and 17 years old.

My dose of psychiatric medication has been stable for at least a month.

Exclusion Criteria

My anxiety only happens during major depression or brain-related conditions.

I have asthma.

Currently enrolled in another device or drug study or less than 30 days has elapsed since participation in such a study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo baseline assessments including the Junior Temperament and Character Inventory (JTCI) and Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)

8 weeks

Treatment

Participants use the Freespira Breathing System for breathing biofeedback

8 weeks

Home-based device usage

Follow-up

Participants are monitored for safety and effectiveness after treatment using various scales such as SCARED, PDSS-A, and CSDS

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Freespira Breathing System

Trial Overview The Freespira Breathing System, which is a drug-free treatment designed to help manage symptoms of anxiety and panic disorders in young people, is being tested for its effectiveness.

How Is the Trial Designed?

Group I: Device Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Palo Alto Health Sciences, Inc.

Industry Sponsor

Trials

3

Recruited

200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9712796/

A 1500 patient effectiveness study - PMC This trial showed significant and sustained symptomatic improvement in panic disorder severity with reported 93% treatment response (≥40% ...

2. health.ny.gov health.ny.gov/health_care/medicaid/ebbrac/meetings/2024/docs/2024-11-07_freespira_rpt.pdf

Freespira for Panic Disorder and Posttraumatic Stress ... A multisite benchmarking trial of capnometry guided respiratory intervention for panic disorder in naturalistic treatment settings. Appl ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02998502

Study Details | NCT02998502 | The Use of a FDA Cleared, ... This study will test the efficiency of the Freespira Breathing System in youth. ... Efficacy of a Biofeedback Breathing System for Anxiety and Panic Disorders.

4. dtxalliance.org dtxalliance.org/products/freespira/

Freespira In clinical trials focused on panic disorder, ≥80% of patients treated reported significant reduction or elimination of symptoms post treatment.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32342249/

Evaluating the Impact of Freespira on Panic Disorder ... 91% had PDSS decrease of ≥ 40%, 73% were PA-free. The majority of patients were panic attack free and/or reduced their symptoms and avoidance behaviors 1-year ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/K180173.pdf

K180173 - accessdata.fda.gov The clinical data demonstrate that Freespira provides a safe and effective, adjunct at-‐home treatment for the symptoms associated with PTSD ...

7. pulmonologyadvisor.com pulmonologyadvisor.com/news/fda-clears-freespira-breathing-system-for-teens-with-anxiety-disorders/

FDA Clears Freespira Breathing System for Teens With ... Freespira receives FDA clearance for adolescents ages 13–17; clinically validated, at-mome treatment reduces panic disorder symptom severity by ...

8. ahn.org ahn.org/services/psychiatry-mental-health/treatments/freespira

What Is Freespira ™ and How Can It Help With Panic ... Freespira is a breakthrough treatment that uses breathing synchronization to normalize CO2 and respiratory rates in a single 28-day treatment course.