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.

What are Panic Attacks and Panic Disorder

In the United States, over 7M people annually suffer from panic disorder (PD), a condition in which the patient has recurrent, unpredictable panic attacks followed by persistent fears about repeat attacks. Panic attacks and fear of potential attacks can have a profound impact on quality of life – resulting in avoidance behaviors such as missing work, not going out with friends, avoiding public places or fear of leaving the house.

Panic attacks are also a common component of other Anxiety Disorders (e.g., Post Traumatic Stress Disorder, Specific Phobias, Social Anxiety Disorder and Generalized Anxiety Disorder), and affect a total of 27M in the US per year. Women are 2-4 times more likely to suffer from PD than men and the most common age group for symptom onset is 25 – 44 years old. PD patients are more likely to commit suicide than depression patients [2,3] and over 25% of them abuse/misuse alcohol [1].

PD patients also consume significantly more healthcare resources than non-PD patients with similar health profiles. A recent analysis conducted by a health economics firm demonstrated that compared with age, gender and health risk-factor matched controls, PD patients:

  • Are 5.4 times more likely to have an any-cause emergency room visit,
  • Have 3.4 times more physician office visits,
  • Have 6 times higher pharmacy claims,
  • Are 5.6 times more likely to develop additional mental health disorders or substance abuse.
[* Source: data on file].

 

Current, evidence-based standards of care to treat PD include Cognitive Behavioral Therapy (CBT) and treatment with benzodiazepines and antidepressants.  Limitations of CBT include cost, limited availability of CBT-trained therapists (only 12% of PD patients receive a formal CBT program), high dropout rates and fear of interoceptive exposure.

Medication limitations include side effects, especially of SSRI/SNRI, risk of abuse of benzodiazepine-class medications and relapse after discontinuation. Of note, 75% of patients say they do not want to take medications and 47% discontinue taking SSRI/SNRIs within 180 days (of these discontinuations, 84% are in the first 90 days).

A recent study published in the Journal of Clinical Psychiatry, reported that when treated with anti-depressants, chronically depressed patients with co-morbid panic disorder experienced greatly increased frequency and intensity of cardiac, gastrointestinal, neurological and genitourinary side effects vs. patients without the co-morbid panic.  In addition, the subjects with depression and co-morbid panic showed a greater risk of worsening depressive symptoms associated with multiple side effects.

These limitations in treating panic with medication or CBT lead patients to continue misinterpreting their panic symptoms as serious medical events, driving increased emergency department and medical specialist visits.

Physiology of Respiration and Panic Attacks

More than 30 years of research has demonstrated that abnormal respiratory function is almost universal in PD patients [4-9]. PD patients chronically hyperventilate and/or exhibit other dysfunctional respiratory patterns leading to lower than normal exhaled carbon dioxide (EtCO2) levels. While significant efforts at studying the role and relationship between abnormal respiration and panic disorder began in earnest in the 1980’s and 90’s, earlier work in the 1940’s by Finesinger identified abnormal sighing frequency in anxiety disorder subjects [8]. Elements of the respiratory pattern that have been studied in PD patients include: respiratory rate, CO2 levels in blood via venous and arterial blood gas sampling (pCO2) and exhaled CO2 readings, minute ventilation, tidal volume and sighing frequency.

Panic attacks are often accompanied by severe respiratory distress (shortness of breath), rapid or irregular heartbeat, chest pain, GI distress and faintness [10]. Several researchers have shown that hyperventilation (rapid respiratory rate and/or increased tidal volume) is a significant factor in the onset and maintenance of panic attacks [11,12]. Studies have also shown that voluntary hyperventilation can induce panic attacks in panic disorder patients [13,14] and that patients with panic disorder demonstrate slower recovery after hyperventilation and are sometimes hypocapnic (exhibit lower than normal CO2 levels) during baseline recordings [15]. Hyperventilation may occur both before and after the attack itself, and can be a chronic condition of which the patient is not aware. [16]. Finally, Klein’s “suffocation alarm hypothesis” [17] suggests that the respiratory abnormalities associated with panic disorder may be due to a hypersensitivity to CO2.

Respiratory Physiology Based Treatment

Starting in 2008, results from a series of clinical studies utilizing feedback of exhaled carbon dioxide (CO2) and Respiration Rate (RR) as a therapeutic approach for panic disorder were reported.  These studies utilized a capnometer (large handheld device with a small monochrome display) displaying real-time and short-term trend display of CO2 plus analog cassette tape recordings of rising and falling tones at specific rates.  Patients followed a three-stage protocol observing their RR and CO2, adjusting breathing rate to be synchronous with the tones and adjusting their inspired air maintain their CO2 in the normal range. This breathing protocol was performed twice-daily for four weeks with the target RR pacing tone rates adjusted weekly from 13 to 11 to 9 and 6 breaths-per-minute and was named capnometry-assisted respiratory training (CART).

Freespira® updates the technology used in the previous studies to include a much smaller, custom sensor and a larger, color display and audible and visual instructions to guide the user.  The sensor links to the tablet via Bluetooth and the custom Freespira application (App) displays the CO2 and RR feedback parameters and full breathing sessions.  Sessions are uploaded to a secure server for remote web access by clinicians to verify adherence and progress.

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.

Publications

Request More Information