FDA authorizes device to relieve PTSD-related nightmares
The device, through the Apple Watch, monitors movement and heart rate to detect nightmares
{{#rendered}} {{/rendered}}The U.S. Food and Drug Administration on Friday authorized a therapeutic using the Apple Watch to help relieve nightmares associated with post-traumatic stress disorder (PTSD), for a better night's rest.
Witnessing shocking or dangerous events can trigger PTSD, the FDA says, which can lead to sleep issues, among its other symptoms.
The therapeutic called NightWare uses the Apple Watch to help relieve nightmares associated with post-traumatic stress disorder, PTSD, for improved sleep. (Photo courtesy of NightWare)
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{{#rendered}} {{/rendered}}“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,” Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a news release. The device was granted through an expedited process with the FDA's so-called "Breakthrough Devices" program.
The newly authorized, prescription-based device is called NightWare, and through the Apple Watch, uses data on body movement and heart rate during sleep to create a sleep profile, per the release. When NightWare detects a nightmare based on its analyses, it releases gentle vibrations “to arouse but not awaken the wearer,” per the company’s webpage, to interrupt the nightmare but allow for continued sleep.
The device monitors movement and heart rate to detect nightmares, upon which would vibrate "to arouse but not awake the wearer" -- to disrupt the nightmare but allow for continued sleep. (Photo courtesy of NightWare).
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{{#rendered}} {{/rendered}}The FDA noted a randomized study on the device involving 70 patients over 30-days, which revealed improvement on sleep scales.
“Patients who have been known to 'act out' during their nightmares (sleepwalking, violence) should not use Nightware,” the FDA added.
Finally, this device should be used in combination with other treatments; it is not a standalone therapy, the agency wrote.
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