The Food and Drug Administration (FDA) has approved 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’s breakthrough 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 a press release by NightWare Inc., a multisite randomized, sham-controlled trial remains ongoing with a planned enrollment of 240 patients. NightWare is available by prescription only and is intended for home use.
“NightWare is not a standalone therapy for PTSD. The device should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder, according to relevant consensus guidelines,” the agency continued.
For related information, see the Psychiatric News article “Digital Nightmare Therapy Receives Breakthrough Designation.”
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