To help sufferers of nightmare disorder and nightmares associated with post-traumatic stress disorder (PTSD), the US Food and Drug Administration (FDA) has given marketing authorization for a wearable device that assists in reducing sleep disturbances associated with nightmares.
Called Nightware, the device is a digital therapeutic that involves the use of an Apple Watch and an Apple iPhone which are connected to a software application and the Nightware server.
The prescription app monitors the wearer’s heart rate and movement as they sleep. If they experience a nightmare, the device nudges the person out of the dream through gentle touch vibrations from the smartwatch, without completely waking them up. The intervention intends to disrupt the nightmare, and not a person’s actual sleep.
Nightware has been approved for adults 22 years or older who suffer from nightmares related to a sleep disorder or PTSD.
The app had been designated a breakthrough device by the FDA in May 2019 for its goal of helping people with PTSD. The federal agency has now granted the maker of the device, Nightware Inc., marketing clearance through the de novo premarket review pathway for new low- to moderate-risk devices.
“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,” said Carlos Pena, director of the FDA’s Office of Neurological and Physical Medicine Devices, in a press announcement from the agency.
“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.”
Nightware uses a proprietary algorithm to develop unique sleep profiles for device users. The profiles are created based on collected heart rate and body movement data during a person’s sleep, which is sent to the Nightware server. When Nightware detects that a patient is experiencing a nightmare based on its data analysis, the device kicks in to provide vibrations through the Apple Watch to subtly and slightly wake the individual from the nightmare. Nightware is available by prescription only and is intended for home use.
This device was evaluated in a 30-day randomized clinical trial involving 70 patients. By being able to interrupt a nightmare, Nightware led to greater improvements in sleep scores when compared to a sham device (which showed some slight improvements). A sham therapy is an inactive treatment or procedure that is intended to closely mimic the investigational therapy. Participants in the sham group wore the device, but no vibratory stimulation was delivered.
Safety was assessed using validated measurements of suicidality and sleepiness; no changes were observed in these measures in both groups during the course of the study. Sleep quality was assessed using a self-rated questionnaire, including one specific to PTSD.
It is estimated that almost five million people in the US suffer from PTSD-associated nightmare disorders. The FDA says that the app is not meant to act as a standalone therapy for PTSD, and should be used together with prescribed medications and therapies. Nightware is intended to be used under the supervision of a healthcare provider, and it is advised that patients who have “acted out” during their nightmares — like sleepwalking or being violent — should not use the device.
The device offers patients a way to manage nightmare episodes for better sleep, and, in turn, experience a better quality of life.