FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults

FDA approved the marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults age 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder. FDA granted the marketing authorization to Nightware, Inc. The company’s device, called Nightware, provides gentle vibration based on an analysis of heart rate and motion during sleep. Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health, said: “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 is a digital therapeutic that uses an Apple Watch and an Apple iPhone that are configured and logged into a software application and Nightware’s server. Apple Watch sensors monitor body movements and heart rate during sleep. Such information is sent to the Nightware server, allowing the device to form a customized sleep profile for the patient based on a proprietary algorithm. When Nightware detects that a patient is experiencing a nightmare, the device provides vibrations through the Apple Watch while the product is in use. Nightware is intended for home use and is available by prescription only.