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FDA approves Apple Watch app that helps people with PTSD sleep better

The FDA designated NightWare a Breakthrough Device, expediting its development and review

NightWare app running on two teal Apple Watches

The Food and Drug Administration (FDA) has approved NightWare, an Apple Watch app that stops nightmare sequences in people with post-traumatic stress disorder (PTSD).

The app uses the Apple Watch’s built-in sensors to monitor the user’s heart rate and movements while they sleep. It then compares the pulse and movements to the user’s baseline sleep profile. If the app detects abnormal movements or heart rate, indicating a nightmare, the smartwatch vibrates to disrupt the nightmare without fully waking the user. 

NightWare also improves its nightmare recognition over time by using artificial intelligence (AI) to analyze sleep and movement data, and making adjustments to the user’s baseline sleep profile.

“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. 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,” said Carlos Peña, Ph.D., director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.

The NightWare app endured a 70-patient, 30-day sham-controlled trial that included a portion of participants getting an inactive placebo-like device. 

The FDA tested NightWare’s safety through suicidality and sleepiness, and neither group showed any change. As for its effectiveness, the FDA’s study leveraged two versions of the Pittsburgh Sleep Quality Index to determine the quality of participants’ sleep. All 70 participants exhibited improved sleep quality, but the group with the active device showed more improvement. The FDA trial not only determined NightWare’s benefits outweighed any risks.

NightWare got fast-tracked in trials thanks to it being an FDA Breakthrough Device, a designation the FDA gives to medical devices it views as effective treatments of life-threatening conditions. Breakthrough Devices receive expedited development and review.  

Despite the fast-tracked approval, the FDA doesn’t recommend NightWare as a standalone treatment for PTSD or the resulting nightmares. The FDA also doesn’t recommend it for those who act out violently or sleepwalk while dreaming. 

Once NightWare completes its clinical trials and is available to the public, it won’t be a downloadable app. Instead, people with PTSD will have to get a prescription, then NightWare will deliver an Apple Watch with the app preinstalled.  

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