NightWare Gets FDA Breakthrough Status for App to Stop Nightmares of PTSD Sufferers

Nightmares are a regular part of life for many people that suffer from post-traumatic stress disorder (PTSD). They can be very hard to control, since dreams seem to have a life of their own and arise in our sleep whether we want them to or not.

NightWare, a company based in Minneapolis, Minnesota, just won FDA Breakthrough Designation for its Apple Watch app that can detect signs of nightmares. The app can make the smartwatch bring the user out of sleep, using slight vibrations, if there is excess signs of a nightmare, as gathered from the watch’s internal sensors, including a heart rate monitor, gyroscope, and accelerometer.

The company is quick to note that the app doesn’t actually wake the wearer of the watch, but instead it just interrupts the sleeping activity. This helps to maintain normal circadian rhythms while alleviating the frequency of nightmares.

The latest designation gives the NightWare app priority review by the FDA when preliminary clinical trials point to a major benefit, helping to bring it to market earlier.

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

Data gathered through the app can be reviewed by clinicians using the NightWare Dashboard, a desktop application that can provide a way to analyze the readings.

The company is now organizing two different clinical trials to test the efficacy of its app and is gathering volunteers with PTSD to participate in these.