NightWare, Inc., a Minneapolis, Minnesota-based mental health digital therapeutics company, as per recent reports, received the “Breakthrough Status” from the US Food and Drug Administration (FDA) for its NightWare Apple Watch app. The app is apt at measuring and treating nightmares in people with Post-Traumatic Stress Disorder (PTSD).
Nightmares and Nightmare Disorder have a direct link to the increased suicidality rates, along with elevated risks for heart diseases, diabetes, and also hampers the cognitive health of an individual, causing memory loss, anxiety, depression, and other physical and mental conditions. As per referencing PTSD diagnoses and PTSD-related CDC data, a whopping 5 million Americans are diagnosed with the Nightmare Disorder each year.
NightWare’s app that runs on the Apple smartwatch platform, collects biometric data through integrated sensors in the smartwatch and uses machine learning algorithms to create the sleep pattern profile of an individual. On the onset of a nightmare, the smartwatch intervenes sending vibrotactile feedback to arouse the sleeper out of sleep without actually waking them. This timely intervention interrupts the nightmare without disturbing the circadian sleep pattern of the patient, thus letting the patient sleep better.
“This is truly a watershed moment for our company,” stated Grady Hannah, CEO & Founder, NightWare. “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.”