FDA gives authorisation for use of device that eases PTSD-related nightmares

The U.S. Food and Drug Administration (FDA) has given its go signal on a device that could help relieve nightmares related to post-traumatic stress disorders (PTSD). Using the Apple Watch, you will be able to have a better night's sleep without having to worry about those horrifying nightmares, brought about by witnessing dangerous or shocking events.

The FDA announced its approval of the new device in a news release. It stated that it is giving its permission to the marketing of a device that could temporarily reduce sleep disturbances, which are related to nightmares among adults aged 22 and above. These adults may be suffering from nightmares brought about by PTSD or simply experiencing a nightmare disorder.

Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the Center for Devices and Radiological Health of the FDA, stated that sleep is an important part of an individual's daily routine. There are times though when a restful sleep becomes elusive for those who are suffering from either a nightmare disorder or from PTSD-related disorders. The new device that the agency has approved is a low-risk treatment option. It utilises digital technology, that would help provide temporary relief from sleep issues brought about by nightmares.

The device goes by the name Nightware. It is a digital therapeutic device, which utilises an Apple Watch and also an iPhone. The devices are configured and while the patient is using it, the application is logged in and connected to the Nightware server.

All throughout the night, the sensors of the Apple Watch monitors the heart rate and the patient's body movement. The data is then sent to the Nightware server for analysis. When Nightware detects that a nightmare occurs based on these data, it will trigger vibrations through the Apple Watch so as to rouse the patient from it. The app is not available for all as it can only be secured via prescription.

To test the efficacy of the device, a 30-day randomised sham-controlled trial was done. A sham therapy is a procedure or inactive treatment that mimics therapies carried out in clinical trials.

In the sham-controlled trial, 70 patients participated. The device was worn by patients in the sham group, however, there was no vibratory stimulation that was provided for them. Sleep of both groups was assessed with the Pittsburgh Sleep Quality Index scale. This is a self-rated questionnaire that assesses sleep quality.

In both the active and sham groups, respondents showed sleep improvement although the active group showed greater improvements compared to the sham group. The FDA noted that in both groups, their evidence shows that the benefits outweigh the probable risks. The agency also underscored that Nightware is not a standalone therapy but must be used together with prescription medicines for PTSD.

Nightware To Relieve Nightmares