Nightware Receives FDA Breakthrough Status for its PTSD Nightmare Therapy App

Nightware PTSD app
Image: Nightware

Many people suffering from post-traumatic stress disorder (PTSD) experience nightmares on a regular basis. Nighttime memories often manifest as distressing dreams or nightmares in which the event is relived. These dreams can be very hard to control, since dreams seem to have a life of their own. 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.

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Minneapolis, Minnesota-based healthcare startup Nightware has received Breakthrough Status designation from the FDA for its lead product, NightWare, which measures and treats nightmares in people with Post-Traumatic Stress Disorder (PTSD).

“We’ve seen a markedly large effect size for improved sleep quality in NightWare open label trials.  We are excited to get folks enrolled in these randomized trials to further verify the observed efficacy,” said Daniel Karlin, M.D. and Chief Medical Officer for NightWare.

NightWare is a smart watch application that runs on the Apple Watch platform. The wearable device collects biometric data through integrated sensors and uses machine learning algorithms to create a profile of an individual’s sleep patterns. The app doesn’t actually wake the wearer of the watch, but instead uses vibrotactile feedback to arouse the sleeper out of sleep. Thus, it interrupts the nightmare without interrupting the circadian sleep pattern, enabling the patient to get better and more restful sleep, said the company in a press release.

Nightmare detecting app
The desktop app displays stress, intervention, and other data collected by the watch app. The desktop app enables an individual to review his or her data or a healthcare professional to review data for multiple users. The goal is to reduce stress levels and interventions over time to ensure restful sleep. (Image: Nightware)

“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.”

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The company 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. Interested parties can get more information about NightWare clinical trial enrollment here.

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Sam Draper () is Online Editor at WT | Wearable Technologies specialized in the field of sports and fitness but also passionated about any new lifestyle gadget on the market. Sam can be contacted at press(at)