The US Food and Drug Administration (FDA) has permitted marketing of a new device that uses Apple Watch to reduce sleep disturbance related to nightmares. The device targets adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD), the FDA said on Friday.
It provides gentle vibration through touch based on an analysis of heart rate and motion during sleep. The device, called Nightware, is a digital therapeutic that uses an Apple Watch and an Apple iPhone that are configured and logged into a software application and the Nightware server.
Throughout the night, Apple Watch sensors monitor body movement and heart rate during sleep. These data are sent to the Nightware server and, using a proprietary algorithm, the device creates a unique sleep profile for the patient.
When Nightware detects that a patient is experiencing a nightmare based on its analysis of heart rate and body movement, the device provides vibrations through the Apple Watch while the product is in use.
Nightware is available by prescription only and is intended for home use, the FDA said. "Sleep is an essential part of a person's daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need," Carlos Pena, Director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, said in a statement.
"Today's authorisation offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares."
PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. People may experience a range of reactions after trauma, and most will recover from their symptoms over time.
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, the FDA said.
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