The "digital therapeutic," uses an Apple Watch to monitor body movement and heart rate to create a sleep profile. During a nightmare, the smartwatch delivers a series of vibrations.
The Apple Watch operates as a highly functional health monitoring wearable. The Apple Watch Series 4, Series 5, and Series 6 allow wearers to take an electrocardiogram to gain a better understanding of their heartbeat and potential warning signs. Earlier this year, Apple added a blood-oxygen oximeter to the latest Apple Watch Series 6 enabling wearers to gauge their current blood-oxygen levels. These new capabilities could be a timely addition amid the coronavirus pandemic. On Friday, the Federal Drug Administration permitted a new device to help reduce the occurrence of nightmares associated with post-traumatic stress disorder (PTSD).
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"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. 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," said Carlos Peña, Ph.D., director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health in a press release.
Many individuals suffering from PTSD experience symptoms ranging from trouble concentrating, irritability, sleep disturbances, regular nightmares, and more. According to the National Center for PTSD, between 71% and 96% of people with PTSD suffer from nightmares. There are a myriad treatment options available including therapies and pharmaceuticals to help those with PTSD.
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The FDA describes the newly permitted device, Nightware, as a "digital therapeutic." Using a connected Apple Watch and iPhone, the digital therapeutic utilizes an app as well as a Nightware server. During sleep, the Apple Watch monitors a person's heart rate and movement. Once sent to the server, these data are then analyzed by an algorithm to create a "unique sleep profile for the patient."
By analyzing the wearer's body movement and heartbeat, Nightware is able to detect when the individual is having a nightmare. Once the device detects a nightmare, the Apple Watch delivers a series of vibrations. Nightwear is currently available via prescription and is only intended for home use, according to the FDA.
During a 30-day randomized, sham-controlled trial involving 70 patients and the new device, "both the sham and active groups showed improvement on the sleep scales," with "the active group showing greater improvement than sham," according to the FDA.
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