FDA Approves Nightmare-Detecting Apple Watch App for Those Suffering from PTSD

An Apple Watch app designed to detect nightmares caused by post-traumatic stress disorder (PTSD) has just received FDA approval. The NightWare app was granted breakthrough status, by the FDA, which fast-tracked the promising therapy through the FDA process.

The NightWare app uses the sensors in the Apple Watch to detect body movements and heart rate during sleep.

These metrics are compiled and sent to the NightWare server, which creates a unique sleep profile for the user.

When a person is sleeping, the NightWare app then analyzes the motion and heart rate data to detect whether the user is having a nightmare.

If a nightmare is detected, the Apple Watch will vibrate to wake up the user and bring them out of their nightmare.

The app passed the FDA’s testing, which included a 30-day randomized, sham-controlled trial with 70 patients.

The test results showed that the app improved sleep quality in users with PTSD. The FDA also stated that the potential benefits of using the app outweigh any negatives.

The FDA warns that the app should not be used by people who act out during nightmares. It also should only be worn while sleeping. Wearing it during the day while reading or watching TV could trigger false alerts.

Though the FDA declared that the app helps with the “temporary reduction of sleep disturbance related to nightmares in adults,” both the FDA and NightWare developers caution that the app should not be used as a stand-alone solution. It is meant to be used alongside counseling, PTSD medication, and other therapies. As a result, the NightWare app is not publicly available and can only be accessed with a prescription.