The app utilizes sensors on the Apple watch to monitor the user’s body movements and heart rate when they are sleeping. Then the data is sent to a server where it is compared based on algorithms to a baseline sleep profile for the user.  

On Friday, the U.S. Food and Drug Administration (FDA) announced that the app has been approved by them.   

In a statement, the FDA said, “This device was studied in a 30-day randomized, sham-controlled trial of 70 patients. A sham therapy is an inactive treatment or procedure that is intended to mimic as closely as possible a therapy in a clinical trial. Patients in the sham group wore the device, but no vibratory stimulation was provided.”  

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Adding, “Safety was assessed using validated measurements of suicidality and sleepiness, and there were no changes in either throughout 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 the sham. The evidence demonstrated the probable benefits outweighed the probable risks.”  

How does the app works: Nightware first decides if the user is experiencing nightmares, if they are then it sends out vibrations through the Apple Watch to disrupt the nightmare.   

Both FDA and Apple do not recommend this app to be a standalone treatment for PTSD based nightmares and is supposed to be used under the supervision of a health care provider. If someone wants to use the app they will require a prescription to use it because it is simply is not for everyone.   

However, this app is not recommended for those who sleepwalk or perform acts of violence. Certain conditions warrant an immediate call to a doctor such as daytime sleepiness.   

If the nightmares continue, Apple recommends users to call a doctor. If in case the vibrations lead to awakenings that are not related to the nightware, users are recommended to discontinue the watch.  

In recent years, Apple Watch has gained a reputation as a lifesaving device as its heart rate monitor has saved several lives.   

Typically, users receive a notification if their heart rate is too low or too high, sending them to the hospital where they are properly diagnosed by a doctor rather quickly.

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