FDA OKs Wearable Treatment for Nightmares

The FDA gave marketing authorization to an Apple Watch app that detects and disrupts nightmares for adults with post-traumatic stress disorder (PTSD) or nightmare disorder, the agency announced Friday.

The so-called NightWare system uses an algorithm that creates a unique sleep profile for each patient based on disruptions in body movements and heart rate. Apple Watch sensors monitor the patient's sleep, sending data to the manufacturer's server which then determines when the patient is having a nightmare. The watch responds by vibrating enough to disrupt the nightmare, typically without fully waking the user.

Patients who experience sleepwalking or violence during nightmares should not use the device, however, and users should contact their doctors if daytime sleepiness persists or if nightmares worsen, according to the FDA.

People with PTSD or a nightmare disorder are often sleep-deprived, said Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, in a statement Friday.

"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," Peña said.

Nightmares of this nature have been associated with increased rates of suicide, heart disease, and other mental health conditions.

The American Academy of Sleep Medicine (AASM) recommends a variety of atypical antipsychotics and tricyclic antidepressants for treating nightmare disorder and PTSD, along with cognitive behavioral therapy.

The system, developed by Minneapolis-based NightWare, is intended to be prescribed along with pharmacotherapy for PTSD and nightmare disorder, the agency stated.

The concept was first developed by a college student seeking to help his father, a U.S. Army sergeant who suffered from PTSD nightmares, said Grady Hannah, NightWare's chief executive officer.

The technology follows the model of service dogs that can be trained to wake their owners during nightmares by licking their face or turning on the lights, Hannah said.

"The nice part about the device is we arouse users enough to take them out of the nightmare, but don't wake them up enough to disrupt sleep," Hannah told MedPage Today.

NightWare is one of many digital therapeutics recently approved to treat mental health conditions. In March, the FDA granted authorization to Somryst, a smartphone-based therapy for insomnia under the same 510(k) premarket process, through which all future digital therapeutics of this nature will pass.

The FDA granted NightWare breakthrough device designation and reviewed it through an expedited process intended for low to moderate risk devices.

Findings from a 30-day trial were key to the agency's decision. Patients wearing a vibrating device showed significantly improved scores on the Pittsburgh Sleep Quality Index scale compared to a sham-controlled group of patients who wore inert devices.

No changes in suicidality and sleepiness occurred in any patients involved in the trial.

NightWare is conducting additional research at Veteran's Affairs hospitals in an ongoing clinical trial, and has plans to conduct a 400-person virtual study.

https://www.medpagetoday.com/psychiatry/sleepdisorders/89560