FDA Approved Apple Watch NightWare App Treats PTSD Nightmares

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NightWare App for Apple Watch Gets FDA Approval as Effective Treatment for PTSD-Related Nightmares

  • NightWare Uses Apple Watch Sensors To Help Those With PTSD Nightmares
  • The app uses machine learning to collect motion and heart rate data
  • If a nightmare is detected, the app signals the Apple Watch to vibrate
  • NightWare has completed its first trials and has been approved by the FDA
  • This is a temporary reduction in sleep disturbances associated with nightmares in adults

By Stacy Liberatore For Dailymail.com

Posted: | Update:

An app designed for Apple Watch has received approval from the Food and Drug Administration (FDA) for effective treatment of nightmares caused by post-traumatic stress disorder (PTSD).

Called NightWare, the application is now marketed as an aid to “temporarily reduce sleep disorders associated with nightmares in adults”.

The app uses Apple Watch sensors to monitor body movement and sleep and when it detects that the user is having a nightmare, the device vibrates to disrupt their sleep.

NightWare is currently only available by prescription and the company stresses that it is not a stand-alone treatment for PTSD.

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About eight million Americans suffer from PTSD and up to 96 percent of them have nightmares as a result.

The disorder is caused by stressful, frightening, or disturbing events, such as serious accidents, abuse, and exposure to combat.

NightWare was designed with the help of Tyler Skluzacek, who started developing the app in 2015 and after the first trials, it received FDA approval to market it as a treatment.

Carlos Peña, Ph.D., director of the Office of Neurological Devices and Physical Medicine at the Center for Devices and Radiological Health, FDA, said: “ Today’s clearance offers a new treatment option low risk that uses digital technology in an effort to temporarily alleviate nightmarish sleep disturbances ”.

“Sleep is an integral part of a person’s daily routine. However, some adults who suffer from a nightmare disorder or suffer from nightmares due to PTSD cannot get the rest they need.

NightWare collects biometric data through sensors built into Apple Watch and uses machine learning algorithms to create a profile of an individual’s sleep patterns.

When a nightmare is detected, Apple Watch vibrates to wake the wearer from sleep without waking them.

NightWare says the interruption does not disrupt the circadian sleep pattern, allowing the patient to achieve better, more restful sleep.

NightWare CEO Grady Hannah said: “ The PTSD population is a high-profile, high-risk population, and providers and payers have prioritized PTSD as an area of ​​focus because it doesn there are not many solutions available. ”

The application has been studied in a 30-day randomized controlled trial involving 70 patients.

Patients in the dummy group wore an Apple Watch, but no vibrational stimulation was provided.

Safety was assessed using validated measures of suicidality and sleepiness, and no changes were observed during the study in either group.

Sleep was assessed using two versions of the Pittsburgh Sleep Quality Index, the self-rated questionnaire for assessing sleep quality, including a version of this scale for patients with PTSD.

The simulated and active groups showed improvement on the sleep scales, with the active group showing greater improvement than the simulated groups.

Evidence has shown that the likely benefits outweigh the likely risks.

While NightWare is not guaranteed to work for everyone, the FDA has stated that it may be effective with other treatments for PTSD.

What is post-traumatic stress disorder (PTSD)

Post-traumatic stress disorder (PTSD) is an anxiety disorder caused by very stressful, frightening, or distressing events.

People with PTSD often suffer from nightmares and flashbacks to the traumatic event and may experience insomnia and an inability to concentrate.

Symptoms are often severe enough to have a serious impact on a person’s daily life and can appear immediately after the traumatic event or years later.

PTSD is thought to affect about one in three people who have a traumatic experience, and was first documented during World War I in soldiers with shell shock.

People who are concerned about having PTSD should see their GP, who may recommend a course of psychotherapy or antidepressants, according to the NHS.

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