FDA approves Apple Watch app NightWare to treat PTSD nightmares

The approval of the app enables NightWare to be marketed as an aid for the "temporary reduction of sleep disturbance related to nightmares in adults," the FDA declared on Friday, including those who suffer from nightmare disorder or have disturbed sleep from post-traumatic stress disorder.

The app uses the sensors on the Apple Watch to monitor body movements and heart rate during sleep, which are analyzed and used to create a sleep profile for the patient. If it is detected that the patient is experiencing a nightmare, by comparing movements and pulse against the sleep profile, the Apple Watch vibrates to disrupt the user's sleep and to bring them out of the nightmare.

Testing of the app determined it was successful in improving the quality of sleep for sufferers, with it outperforming a control group as part of the "sham-controlled trial."

While NightWare is an app, it isn't one that will be readily available to use by anyone. It is available by prescription only, is intended to be used alongside prescribed PTSD medications and other therapies, and under the supervision of a healthcare provider.

Furthermore, the FDA warns the app should not be used by patients who "act out" during nightmares by sleepwalking or being violent, nor to be used while reading or watching television to prevent false alerts.

The app was granted a "Breakthrough Device" designation for treating PTSD nightmares, a process that is designed to speed up the development and review of hardware and services that could offer effective treatment or diagnosis for life-threatening or "irreversibly debilitating diseases or conditions."

While it isn't directly consumer-usable, the app is certainly an extension to Apple's existing efforts to improve the sleeping habits of its customers. The Sleep Mode and sleep tracking in iOS 14 and watchOS 7 offers reports to users on how well they sleep, as well as encouraging healthy habits in winding down to sleep at appropriate times.