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The NightWare digital therapeutic is indicated to provide vibrotactile feedback on an Apple Watch based on an analysis of heart rate and motion during sleep for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from posttraumatic stress disorder (PTSD). It is intended for home use.

The NightWare device consists of a software application and the NightWare server. The device uses an Apple Watch and an Apple iPhone for its platform. Patients must use the prescribed iPhone and Apple Watch pre-provisioned by NightWare, Inc. The watch monitors physiological parameters that indicate that the patient is experiencing a nightmare. Signals from the watch's heart rate sensor, accelerometer, and gyroscope are input to the onboard algorithms on the watch software and sent to the server and processed by NightWare software. The software on the server calculates a device-specific "Stress Index" from watch measurements of heart rate, rotation, and acceleration. When a "Stress Index" threshold is exceeded, the device provides a vibrotactile stimulation on the patient's wrist intended to interrupt the nightmare but not awaken the patient. Patients need to have at least an intermittent connection to wireless internet through WiFi in order to transmit data to the NightWare server. However, this wireless internet connection is not needed to receive therapy through the treatment period, as the processing of physiological data and delivery of stimulation occurs on the watch itself. The "Stress Index" threshold is uniquely calculated for each patient based on an artificial intelligence algorithm. The algorithm differentiates between a patient's normal and abnormal "Stress Index" levels during the night. To create its personalized "Stress Index" threshold, NightWare collects several hours of data during sleep before any intervention is applied. During this initial time, the system monitors the patient's movements and heart rate to delineate the usual low, medium, and high "Stress Index" periods to determine the wearer's usual sleep patterns. The movement and heart rate information is then securely sent to the NightWare server to establish the patient's specific "Stress Index" threshold; when the threshold is reached the vibrotactile stimulation is applied. The "Stress Index" threshold is automatically and periodically updated as needed to accommodate the patient's changing "Stress Index" and thresholds that naturally occur during consistent use.