Nearly all patients who have post-traumatic stress disorder (PTSD) experience some type of sleep disturbance. Research suggests that almost two-thirds of PTSD patients have frequent, vivid nightmares. Help is on the way, and it can be as close as your wrist. The FDA recently permitted marketing for Nightware, a device that works with an Apple watch to reduce sleep disturbance related to nightmares, especially those associated with PTSD.
Essentially a flashback that occurs during sleep, post-traumatic nightmares might involve a replay of traumatic events or relate to the trauma through symbols or associations. Many patients have nightmares several times per week; untreated, they can continue for months or years. Post-traumatic nightmares affect sleep quality and can even lead to sleep avoidance, which holds its own mental health risks.
Adults age 22 and above who experience PTSD nightmares or suffer from nightmare disorder can now use Nightware to obtain more restful sleep. Nightware integrates with Apple Watch, using data on nighttime motion and heart rate to create a personalized user sleep profile. When the Nightware software detects that the user is having a nightmare, it signals the Apple Watch to provide calming vibrations without waking the individual. In a 30-day trial, Nightware users reported a greater reduction in sleep disturbance than a control group who received a sham treatment.
To expedite its availability for qualified patients, the FDA granted Nightware a Breakthrough Device designation, making it eligible for an accelerated development and review process. As the first device of its kind, it was reviewed through the De Novo premarket pathway. This pathway allows the FDA to establish new controls and guidelines to guarantee novel medical devices’ safety and effectiveness.
Nightware requires a prescription and should be used under the supervision of a healthcare provider. It’s not a standalone PTSD treatment and should always be used in conjunction with therapy and other established PTSD protocols.