The Food and Drug Administration (FDA) has granted Breakthrough Status designation to NightWare (NightWare, Inc.), a digital intervention therapy that measures and treats nightmares in patients with post traumatic stress disorder (PTSD).

NightWare runs on the Apple Watch platform via a smartwatch application. This device is able to create a profile of a patient’s sleep patterns through integrated sensors and machine learning algorithms, typically after a learning period of less than 10 days.

At the onset of a nightmare, the patient is aroused from sleep (without awakening) using vibrotactile feedback so that the nightmare is interrupted prior to the patient waking up in distress. The device will not affect the circadian sleep pattern of the patient; if it senses that the patient is being woken by the vibrations, it will vibrate less the next time.

A desktop app, which displays the data collected by the smartwatch app, allows healthcare providers to review individual patient data in order to provide guidance on managing their nightmare disorder.

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The Company is currently enrolling patients in randomized clinical trials, one of which will be virtual. Patients interested in participating in a trial can get more information here.

“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,”  said NightWare CEO and Founder Grady Hannah.

NightWare is a private digital therapeutics company headquartered in Minneapolis, MN with a platform designed to treat nightmare disorder. It is currently seeking FDA clearance for commercial sales as a medical device.

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