09.11.2020
11:08
This is Nightware, available for the Apple smart watch
By Desirée Jaimovich November 9, [email protected] Share on FacebookShare Share on TwitterTweet Share on WhatsAppShare
NightWare is an application on an Apple Watch that helps people who suffer from nightmares get a good night’s sleep
The US Food and Drug Administration (FDA) authorized the marketing of Nightware, an application for Apple Watch designed to reduce sleep disorders linked to frequent nightmares that can occur in people suffering from post-traumatic stress disorder (PTSD) .
The app, which works on Apple watches, generates a gentle vibration on the user’s wrist in order to interrupt that bad dream without waking it up , so that the person can get a good night’s sleep . As it does? NightWare learns sleep patterns and customizes a treatment for each individual, based on the information collected.
NightWare will be sold by prescription only. This technology is only part of a strategy that must include other aspects that will be indicated by the treating physician. “The device should be used in conjunction with prescription medications for post-traumatic stress disorder and other recommended therapies for nightmares and nightmare disorder associated with post-traumatic stress disorder, according to the relevant consensus guidelines,” the statement from the FDA where it is also advised that patients who suffer from sleepwalking and act violently during sleep should not use Nightware.
“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience PTSD nightmares cannot 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 disorders related to nightmares, ”said Carlos Peña, Ph.D., director of the Office of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health, in a statement posted on the official website.
The app generates a gentle vibration on the user’s wrist with the aim of interrupting that bad dream, without waking them up, so that they can achieve a restful rest
How Nightware works
Nightware is a digital therapy system that uses an Apple Watch and an iPhone that are configured and connected to a software application and the Nightware server. During the night, Apple Watch sensors monitor body movement and heart rate during sleep.
This data is 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 worn, as detailed on the official FDA site.
Nightware was evaluated in a sham controlled trial that involved following 70 patients for 30 days . A sham therapy is an inactive treatment or procedure that is intended to mimic as much as possible a therapy in a clinical trial. The patients in the sham group used the device, but were not given vibratory stimulation.
Two versions of the Pittsburgh Sleep Quality Index scale, the self-rated questionnaire to measure sleep quality, including a version of this scale for PTSD patients were used for the assessment. Both the sham and the active group showed an improvement in the sleep scales, and the active group showed a greater improvement than the sham. The evidence showed that the likely benefits outweighed the likely risks.
