NightWare™, Digital Therapeutic SystemItem #: 100001
NightWare™ is a digital therapeutic system designed and indicated to treat nightmares associated with PTSD. NightWare stops nightmares but avoids the side effects and complications associated with pharmaceuticals. NightWare’s system uses patented artificial intelligence algorithms to treat nightmares. It pairs cloud-based AI with the easy-to-use Apple Watch and iPhone ecosystem. NightWare develops a customized treatment plan for each patient. It collects high-fidelity data such as beat-to-beat heart rate variability, accelerometry, and gyroscope data that is monitored and analyzed continuously. NightWare then applies artificial intelligence to calculate a patient’s unique “stress index” to create a personalized treatment that is unique to each patient. The treatment is delivered to the patient through the Apple Watch via vibrotactile interventions. Through continuous monitoring the NightWare AI will improve over time. NightWare is a Class II medical device that received clearance from the FDA in November, 2020. It is only available by prescription.
- All-in-one digital therapeutic system that delivers NightWare's customized treatment to improve sleep disturbance from nightmares associated with PTSD
- Dedicated device and software platform that operates on the easy-to-use Apple Watch and iPhone ecosystem
- Uses artificial intelligence to develop a custom treatment for each patient that learns and improves as it gathers biometric information from the patient
- Predicts and interrupts a patient’s nightmare through vibrotactile feedback delivered through the Apple Watch
- An FDA cleared, Class II medical device, for prescription use only
- NightWare's digital therapeutic system is a durable medical device that is a one-time purchase; the NightWare system includes NightWare user guide , Belkin Dual USB Powerblock, Apple Watch SE, Apple iPhone SE, Prescriber introductions for use, Patient instructions for use, and Patient quick reference guide