The FDA has cleared a smartwatch app that delivers digital therapy to alleviate the effects of nightmares associated with post-traumatic stress disorder (PTSD).

The machine-learning application by Minneapolis-based startup NightWare offers treatment without pharmaceuticals and runs on the Apple Watch. The company’s app can collect high-resolution biometric data, analyze sleep patterns, pinpoint the onset of a nightmare and provide vibrotactile feedback to arouse the patient without completely waking them to enable more restful sleep, according to NightWare.

The app was studied in a 30-day randomized, sham-controlled trial of 70 patients, according to the FDA. Safety was assessed using validated measurements of suicidality and sleepiness, and there were no changes in either over the course of the study in either group. Sleep was also assessed with two versions of the Pittsburgh Sleep Quality Index scale, the self-rated questionnaire for assessing sleep quality, including a version of that scale that is intended for patients with PTSD. Both the sham and active groups showed improvement on the sleep scales, with the active group showing greater improvement than sham. The evidence demonstrated the probable benefits outweighed the probable risks, according to the FDA.

“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,” said Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a news release. “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 previously obtained FDA breakthrough device designation and submitted for clearance in May 2020. It is available by prescription only and is intended for home use.