FDA-approved Apple Watch NightWare app treats PTSD-linked nightmares

NightWare app for Apple Watch wins FDA approval as an effective treatment for PTSD-related nightmares

  • NightWare uses Apple Watch sensors to help those with PTSD nightmares
  • The app uses machine learning to collect data on movement and heart rate
  • If a nightmare is detect, the app signals the Apple Watch to vibrate
  • NightWare completed its first trials and was approved by the FDA
  • It is a temporary reduction of sleep disturbances related to nightmares in adults

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

Called NightWare, the application is now marketed as an aid for the ‘temporary reduction of sleep disturbances related to nightmares in adults.’

The app uses Apple Watch sensors to monitor body movement and sleep and when it detects the user is experiencing a nightmare, the device will vibrate to disturb their sleep.

NightWare is currently only available with a prescription and the company stresses it is not a standalone treatment for PTSD. 

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Approximately 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 combat exposure.

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

Carlos Peña, Ph.D., director of the Office of Neurological and Physical Medicine Devices in the 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.’

‘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.’

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

When a nightmare is detected, the Apple Watch will vibrate to arouse the wearer out of sleep without waking them.

NightWare says the interruption does not disturb  the circadian sleep pattern, enabling the patient to get better and more restful sleep.

NightWare CEO Grady Hannah said: ‘The PTSD population is a high visibility and high risk population and care providers and payers have prioritized PTSD as an area of focus since there’s not a lot of available solutions.’

The app was studied in a 30-day randomized, sham-controlled trial of 70 patients.

Patients in the sham group wore an Apple Watch, but no vibratory stimulation was provided.

Safety was assessed using validated measurements of suicidality and sleepiness, and there were no changes in either over the course of the study in either group.

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

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

The evidence demonstrated the probable benefits outweighed the probable risks. 

Although NightWare is not guaranteed to work for everyone, the FDA said it can be effective with other PTSD treatments. 

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 nightmares and flashbacks to the traumatic event and can experience insomnia and an inability to concentrate.    

Symptoms are often severe enough to have a serious impact on the person’s day-to-day life, and can emerge straight after the traumatic event or years later. 

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

People who are worried they have PTSD should visit their GP, who could recommend a course of psychotherapy or anti-depressants, the NHS say. 


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