FDA OKs App That Disrupts Nightmares Associated With PTSD

The Food and Drug Administration (FDA) hasapproved the marketing of NightWare —artificial intelligence software shown to reduce sleep disturbances in people experiencing nightmares related to posttraumatic stress disorder (PTSD) or nightmare disorder.In May 2019 NightWare received the FDA ’sbreakthrough device status designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.NightWare uses artificial intelligence software installed on an Apple Watch to monitor the user ’s heart rate and movement while sleeping. When NightWare detects that the user is experiencing a nightmare based on its analysis of heart rate and body movement, the device emits a vibration through the Apple Watch before the nightmare reaches a severity that would awaken the user.The device was evaluated in a 30-day randomized, sham-controlled trial of 70 patients, according to the FDA release. The researchers used two versions of the Pittsburgh Sleep Quality Index scale to compare outcomes among participants in the sham group (wore the device but received no stimulation during nightmares) with those in the active group (wore the device and received stimulation during nightmares). “Both the sham and active groups showed improvement on the sleep scales, with the active group showing greater improvement than sham,” the FDA reported.According to apres...
Source: Psychiatr News - Category: Psychiatry Tags: breakthrough device FDA nightmare disorder nightmares NightWare posttraumatic stress disorder PTSD Source Type: research