About Freespira®

FreespiraFreespira is an FDA-cleared, medication-free digital therapeutic to treat panic disorder and its symptoms, including panic attacks. Patients that experience panic attacks co-morbid with other anxiety disorders such as PTSD, General Anxiety Disorder, and depression can also be treated. Freespira is authorized by a licensed provider then patients are trained by a clinician and complete twice-daily breathing sessions at-home for 4 weeks.  Freespira is used to prevent or eliminate panic symptoms, rather than to interrupt a panic attack in process.

Panic disorder and its symptoms, notably panic attacks, are common, life-impairing conditions also associated with excessive health spending and negative workplace impact.  Freespira comprises of a specially designed, custom sensor that measures a patient’s exhaled carbon dioxide (EtCO2) levels and respiratory rate (RR) in real-time. This physiologic data is then transmitted to a tablet where a custom App guides and directs the patient through a 17-minute breathing protocol.  The 17-minute sessions are done twice-daily for 4 weeks at-home by the patient. The physiologic data is automatically uploaded to a secure server for review by the clinician or a Freespira Customer Care team member to verify adherence and progress. After 4 weeks, the treatment is complete and Freespira is returned.

This patient-directed protocol directly targets the respiratory dysfunction at the core of panic disorder and panic symptoms. Published randomized controlled trials have demonstrated elimination of panic attacks in 79% of users 12 months post-treatment, and clinically significant improvement in over 82% of users.

Clinical Results

Results from the capnometry-assisted respiratory training (CART) protocol clinical trial at Stanford University and other academic centers demonstrated a reduction in panic symptoms, including panic attacks, with 68% of patients panic attack free at 12 months post-treatment. Other studied outcome measures also improved such as the Panic Disorder Severity Scale (PDSS), Clinician’s Global Impression (CGI), and self-reported measures of anxiety [18].

A larger multi-center Freespira study, recently published in the peer-reviewed Journal Applied Psychophysiology and Biofeedback. [40], studied patients in a community (non-academic) setting, across a broad spectrum of patient demographics and symptom severity.  This study demonstrated similar and in some cases improved outcomes than the original randomized Stanford trial.   As before, patients performed two 17-minute breathing sessions per day for 4 weeks at-home controlling their RR and CO2 by reference to the real-time feedback provided by the App.  After completion of the one month treatment, Freespira equipment was returned and subjects were followed at 2- , 6- and 12-months. Patient compliance was excellent; 86% of patients completed the 4-week at-home treatment protocol.  Results include:

Freespira Multi-Center Clinical Trial Data

Tolin, D.F., McGrath, P.B., Hale, L.R., Weiner, D.N. et al. (2017). A Multisite Benchmarking Trial of Capnometry Guided Respiratory Intervention for Panic Disorder in Naturalistic Treatment Settings. Journal of Applied Psychophysiology and Biofeedback, March 2017, Volume 42, Issue 1, pp 51–58.

In these studies, patients experienced significant and long-lasting reductions in panic attack frequency and severity, anxiety symptoms, and avoidance behaviors.  Patients also reported improvements in mood and quality of life and no serious adverse events were reported in either study.  An overwhelming majority of patients – 86% — reported satisfaction with the treatment, saying they would recommend it to a friend or family member.

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