Zeitschrift für traumatische Belastungsstörungen und Behandlung

A Pilot Investigation of the Effectiveness of the Sana Device in Management of PTSD: A Blinded Randomized Controlled Trial

Stephanie Hart, Wendy Muzzy, Michelle Pompei, Jeffrey Bower, Mark Robberson, Richard Hanbury, Ronald Acierno

Objective: Post-traumatic Stress Disorder (PTSD) is a chronic and debilitating condition affecting millions of Americans, particularly veterans. Repercussions of PTSD are multifaceted, encompassing psychological, physical, and social challenges. Frontline pharmacological treatments only offer limited relief and come with detrimental side effects. Psychological treatments like Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT) are often poorly tolerated by patients leading to early discontinuation of treatment. There is an urgent need for additional treatment options that can be used in addition to the current pharmacological and psychological therapies for those with PTSD. The present study investigated the Sana Device, a neuromodulatory Audio-Visual Stimulation (AVS) device designed to remediate symptoms of PTSD. Methods: We conducted a randomized, parallel-arm, controlled trial with 48 Veterans age 18-65 diagnosed with PTSD who were seeking services from a Southeastern Veterans Affairs Hospital to investigate effectiveness of the Sana device plus best practices PTSD Treatment as Usual (Sana+TAU) relative to best practices Treatment as Usual (TAU) alone for treating PTSD. Participants were asked to use the Sana device with best practices TAU or continue best practices TAU alone for 28 days. Patients were assessed on PTSD symptoms (CAPS-5 & PCL-5), anxiety (GAD7), depression (PHQ-9), and quality of life (PGIC-QOL). Results: Significant improvements were evident in Sana+TAU vs. TAU for PTSD symptom severity (PCL-5 p < 0.001). In addition, there were significant improvements for the Sana+TAU arm over TAU alone for anxiety (GAD-7: p < 0.001), depression (PHQ-9: p < 0.001), and for Quality of Life (PGIC-QOL: p < 0.001). Conclusion: The Sana Device + TAU was more effective than best practices TAU alone for improving PTSD symptoms, anxiety, depression, and quality of life for patients with PTSD. The Sana device shows promise as an effective novel treatment for PTSD that is easy to use, largely free of side effects, and works alongside existing treatments.