FDA clears device to relieve PTSD nightmares



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The US Food and Drug Administration on Friday authorized therapy using the Apple Watch to help relieve nightmares associated with post-traumatic stress disorder (PTSD), for a better night’s sleep.

Witnessing shocking or dangerous events can trigger PTSD, according to the FDA, which can lead to sleep problems, among its other symptoms.

The therapy called NightWare uses the Apple Watch to help relieve nightmares associated with post-traumatic stress disorder, PTSD, for improved sleep.  (Photo courtesy of NightWare)

The therapy called NightWare uses the Apple Watch to help relieve nightmares associated with post-traumatic stress disorder, PTSD, for improved sleep. (Photo courtesy of NightWare)

PTSD IN CORONAVIRUS SURVIVORS, PHYSICIANS BECOMING A NEW GOAL FOR HOSPITALS ACROSS THE UNITED STATES

“Today’s clearance offers a new low-risk treatment option that uses digital technology with the aim of temporarily alleviating sleep disturbances associated with nightmares,” Carlos Peña, director of the Office of Neurological Medicine Devices and FDA’s Center for Devices Physics and Radiological Health, said in a press release. The device was granted under an expedited process with the FDA’s Breakthrough Devices program.

The newly licensed 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, according to the version. When NightWare detects a nightmare based on its scans, it releases gentle vibrations “to excite but not wake the wearer,” according to the company’s webpage, to interrupt the nightmare but allow continued sleep.

The device monitors movements and heart rate to detect nightmares that vibrate "to wake up but not wake up the wearer" - to disrupt the nightmare but allow continuous sleep.  (Photo courtesy of NightWare).

The device monitors movement and heart rate to detect nightmares, which would vibrate “to wake up but not wake the wearer” – to disrupt the nightmare but allow continued sleep. (Photo courtesy of NightWare).

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The FDA noted a randomized study of the device involving 70 patients over 30 days, which found improvement in 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 must be used in combination with other treatments; it is not stand-alone therapy, the agency wrote.

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