NightWare, Inc., digital therapeutics for mental health company has received Breakthrough Status designation from the U.S. Food and Drug Administration (FDA) for its NightWare Apple Watch app that measures and treats nightmares in people with Post-Traumatic Stress Disorder (PTSD).
Impact of Nightmare Disorders
Nightmares and Nightmare Disorder have been linked to increased suicidality, heightened risk of heart disease, diabetes, and contributes to cognitive difficulties such as memory loss, anxiety, depression and other physical and mental conditions. It is estimated that nearly 5 million Americans suffer from Nightmare Disorder in the U.S. each year through referencing PTSD diagnoses and CDC data relating to PTSD.
What is NightWare?
NightWare is a smartwatch application that runs on the Apple Watch platform. The device collects biometric data through integrated sensors and uses machine learning algorithms to create a profile of an individual’s sleep patterns. At the point the onset of a nightmare is detected, the device intervenes using vibrotactile feedback to arouse the sleeper out of sleep without waking them. The result is that the nightmare is interrupted without interrupting the circadian sleep pattern, enabling the patient to get better and more restful sleep.
Significance of FDA “Breakthrough Status”
This FDA designation recognizes a therapeutic solution for a life-threatening condition for which no currently approved treatment offers similar benefits to those of the proposed therapy. The designation allows the FDA to grant priority review when preliminary clinical trials indicate that a given therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.
“This is truly a watershed moment for our company,” said NightWare CEO and Founder Grady Hannah. “In our initial studies, NightWare has demonstrated substantial and significant efficacy.
The FDA’s Breakthrough Status designation will enable us to complete our Randomized Clinical Trials ahead of schedule and give us the opportunity to help improve the lives of veterans and others suffering from PTSD sooner than we anticipated.” Hannah added, “Our team is humbled and excited by this FDA designation.”
NightWare is currently enrolling patients in two Randomized Clinical Trials (RCTs), one of which is being conducted at VA hospitals in Minneapolis and St Cloud, Minnesota. The company is also enrolling a virtual RCT trial that is much broader in geographic scope.