• by P.J. Bednarski  @pjbtweet, November 9, 2020

The Food and Drug Administration has approved the sale of a new Apple Watch app called NightWare that can help people suffering from “traumatic nightmares” to get a good night’s sleep.

It does that by interpreting a user’s sleep patterns and gently interrupting what the device interprets as nightmares.

The FDA says NightWare, which will be an app available only via prescription, is not a stand-alone treatment for post-traumatic-stress-disorder nightmares, but can be used with other physician-prescribed therapy.

The FDA’s Dr Carlos Pena, director of the Office or Neurological and Physical Medicine Devices, said last Friday,  “Today’s authorization offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares.”

The NightWare company, which has the financial support of the Minnesota Department of Veterans Affairs, is based in Minneapolis and has a bit of a pedigree. It attracted investor acclaim at last year’s J.P. Morgan Healthcare Investment Conference that considered “flyover” tech innovators.

The Department of Veteran Affairs estimates that 4% of men and 10% of women suffer from PTSD at some point in their lives, and about eight million suffer from it somet ime in any given year.

Another VA study shows between 71%-96% of military people with PTSD have nightmares.

The device uses an Apple Watch and an Apple iPhone logged into a software application and the NightWare server.

Throughout the night, Apple Watch sensors monitor body movement and heart rate, sending that information to a  NightWare server. With a  proprietary algorithm, the device creates a unique sleep profile for the patient. When it notices a nightmare based on heart rate and body movement, it buzzes the user via the Apple Watch.  

The company says it takes about 10 days of use for the device to “learn” a user’s heat rate and typical movements.  In time NightWare also learns to regulate the intensity  of the vibration so that it only interrupts the nightmare without awakening the user.

NightWare  comes with some unusual warnings. The FDA says the watch that is part of the NightWare kit shouldn’t be worn while a user is reading or watching television, which could trigger false alerts. And a bed partner might be bothered by the app’s vibration, so a user is advised to keep it away from the person sleeping next to them.

Also, the FDA says NightWare shouldn’t be used by patients who sometimes “act out” on their nightmares by sleep walking, for example.

The device comes to market in a relatively unusual way. The FDA said NightWare was granted “Breakthrough Device designation,” which allows expedited development and review of products that can bring more effective treatment and diagnosis of “life-threatening or irreversibly debilitating diseases or conditions.”