The majority of post-traumatic stress disorder (PTSD) patients suffer from frequent traumatic nightmares that can deeply disrupt sleep patterns and have been linked with significantly higher rates of suicide. The U.S. Food and Drug Administration (FDA) has now approved a platform called NightWare, designed to help improve sleep in PTSD patients suffering from such recurrent nightmares. The system is an app that runs on Apple Watches and will only be available by prescription.
“Disruptive and persistent traumatic nightmares associated with post-traumatic stress are significantly underreported and undertreated, and there are no consistently effective treatment options,” explains retired US Army General and NightWare advisor Peter Chiarelli. “A device such as the NightWare therapeutic platform that performs the necessary reconnaissance of the mind to identify and interrupt post-traumatic stress-associated nightmares represents a transformational step forward in how we can begin to better support our veterans and active service members suffering from this disabling condition.”
The NightWare system is essentially a sophisticated app that works with an Apple Watch and linked smartphone, and initially spends up to 10 nights learning a user’s sleep patterns. Once a unique sleep profile has been created, the system tracks heart rate and body movement data to detect when a user is experiencing a nightmare. If a nightmare is detected the system triggers mild vibrations through the Apple Watch that are designed to gently disrupt the nightmare without waking the user.
The system was tested in a sham-controlled clinical trial that recruited 70 PTSD patients. The control group received exactly the same intervention as the active group. They used the app and wore a connected Apple Watch, except they received no vibratory stimulation.
The results suggest the NightWare system offered clinically significant improvements to sleep quality, compared to the sham control group. This clinical trial is still ongoing and the plan is to ultimately recruit 240 subjects by the end of 2021.
Based on early clinical data the FDA first granted NightWare a Breakthrough Device designation in 2019. This subsequent full marketing approval makes the system the first therapeutic system of its kind to garner this FDA approval.
However, the FDA’s approval does come with a number of limitations. As the device is being marketed as a therapy for a medically diagnosed condition it will only be accessible via a prescription from a healthcare provider. The FDA also makes clear NightWare is not a standalone therapy, but instead should only be used as part of a broader treatment protocol involving either medications or psychotherapy.
“Sleep is an essential part of a person’s daily routine,” says Carlos Peña, from the FDA’s Center for Devices and Radiological Health. “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.”
NightWare is not the first prescription-only app to get a thumbs-up from the FDA, which is still developing a regulatory model for how to manage software-based medical devices, referred to as "prescription digital therapeutics," in the future.
