FDA clears Apple Watch sleep app that intervenes to stop nightmares caused by PTSD

The FDA has cleared an app for the Apple Watch to help people suffering from nightmares or post-traumatic stress disorder (PTSD) get a better night’s sleep.

Dubbed Nightware, the prescription app monitors the wearer’s heart rate and movement while they sleep—and, if they’re having a nightmare, gently prods them out of the dream without aiming to wake them up completely, using the smartwatch’s vibrations.

The agency designated the app a breakthrough device in May 2019 for its promise to help adults with PTSD, and it has now granted the program a de novo clearance.

A randomized clinical trial showed that the ability to intervene in a nightmare led to improvements in sleep scores after 30 days, when compared to a sham device that provided no vibrations, according to the FDA.

“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need,” said Carlos Pena, director of the FDA’s Office of Neurological and Physical Medicine Devices. “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.” 

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The program uses a proprietary algorithm to generate a personalized sleep profile for each user to detect when they are having a nightmare by recording when the biometric data breaks from the norm.

Nightware estimates that nearly 5 million people in the U.S. suffer from nightmare disorders related to PTSD. The app is not meant to act as a standalone therapy for PTSD, and it should be used alongside any prescribed medications and other therapies.